## Protocol Section
### Identification Module
**NCT ID:** NCT02655679

**Brief Title:** An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis

**Official Title:** A Randomized, Double-Blind, Vehicle-Controlled Ascending Multiple Dose and Clinical Proof-Of-Concept Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-38543 in Adult Patients With Mild to Moderate Atopic Dermatitis

#### Organization Study ID Info
**ID:** VTP-38543-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Vitae Pharmaceuticals, Inc.
### Status Module
#### Completion Date
**Date:** 2016-09-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-02-15

**Type:** ACTUAL

**Last Update Submit Date:** 2019-01-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-09-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-02-15

**Type:** ACTUAL

**Results First Submit Date:** 2019-01-18

**Results First Submit QC Date:** 2019-01-18

#### Start Date
**Date:** 2015-12-15

**Type:** ACTUAL

**Status Verified Date:** 2019-01

#### Study First Post Date
**Date:** 2016-01-14
**Type:** ESTIMATED
**Study First Submit Date:** 2016-01-11
**Study First Submit QC Date:** 2016-01-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Vitae Pharmaceuticals, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

**Detailed Description:** This is a randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 following twice-daily, every twelve hours (Q12h) administration for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

Evaluation of three ascending doses in three dose panels is planned for this trial. Dose Panel 1 (VTP-38543 0.05%) and Panel 2 (VTP-38543 0.15%) will each enroll 30 participants and randomize 20 to VTP-38543 and 10 to matching vehicle control (Vehicle without Transcutol®P). Dose Panel 3 (VTP-38543 1%) will enroll 40 participants and randomize 20 to VTP-38543 and 20 to matching vehicle control (Vehicle with Transcutol®P). A total of approximately 100 participants will participate in the trial.

### Conditions Module

**Conditions:**

- Dermatitis, Atopic

**Keywords:**

- Eczema

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 104

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.

**Intervention Names:**

- Drug: VTP-38543

**Label:** VTP-38543 0.05%

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.

**Intervention Names:**

- Drug: VTP-38543

**Label:** VTP-38543 0.15%

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.

**Intervention Names:**

- Other: Vehicle without Transcutol®P

**Label:** Vehicle without Transcutol®P

**Type:** PLACEBO_COMPARATOR

#### Arm Group 4

**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.

**Intervention Names:**

- Drug: VTP-38543

**Label:** VTP-38543 1%

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.

**Intervention Names:**

- Other: Vehicle with Transcutol®P

**Label:** Vehicle with Transcutol®P

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- VTP-38543 0.05%

- VTP-38543 0.15%

- VTP-38543 1%

**Description:** VTP-38543 topical cream

**Name:** VTP-38543

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Vehicle with Transcutol®P

**Description:** Vehicle matching VTP-38543 cream with Transcutol®P

**Name:** Vehicle with Transcutol®P

**Other Names:**

- Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Vehicle without Transcutol®P

**Description:** Vehicle matching VTP-38543 cream without Transcutol®P

**Name:** Vehicle without Transcutol®P

**Other Names:**

- Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.

**Measure:** Number of Participants With Treatment-related Adverse Events (AEs)

**Time Frame:** Baseline (Day 0) to Day 35

**Description:** Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.

**Measure:** Number of Participants With Clinically Significant Changes in Clinical Laboratory Values

**Time Frame:** Baseline (Day 0) to Day 35

**Description:** Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.

**Measure:** Number of Participants With Clinically Significant Changes in Vital Signs

**Time Frame:** Baseline (Day 0) to Day 35

**Description:** A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.

**Measure:** Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values

**Time Frame:** Baseline (Day 0) to Day 35

#### Secondary Outcomes

**Measure:** Maximum Plasma Concentration (Cmax) for VTP-38543-001

**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)

**Measure:** Time to Maximum Plasma Concentrations (Tmax) for VTP-38543

**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)

**Measure:** Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543

**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)

**Measure:** Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543

**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)

**Measure:** Elimination Half-life (t½) for VTP-38543

**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)

**Description:** Percent BSA was estimated using the palmar surface of the participant's hand up to the proximal interphalangeal joint, including the thumb, to approximate 1% of the participant's BSA. The overall BSA affected by atopic dermatitis was evaluated from 0 to 100% and divided by 5 for a maximum of 20. A negative percentage change indicates improvement.

**Measure:** Percentage Change From Baseline in Total Body Surface Area (BSA)

**Time Frame:** Baseline (Day 0) to Day 28

**Description:** The investigator assessed the participant's atopic dermatitis using the 5-point IGA where 0=clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting) to 4=Severe disease (Deep/bright red erythema with severe induration/papulation with oozing/crusting). A negative percentage change indicates improvement.

**Measure:** Percentage Change From Baseline in Investigator Global Assessments (IGA) Score

**Time Frame:** Baseline (Day 0) to Day 28

**Description:** The investigator assessed severity of atopic dermatitis (AD) using scoring atopic dermatitis (SCORAD) score obtained from different individual scales. 6-items: erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness were graded on a 4-point scale where 0=Absent to 3=Severe. The individual scores were added together to get a score of 0 to 18 that was multiplied by 3.5 for a score of 0 to 63. The overall BSA affected by AD (0 to 100 %) was divided by 5 for a score 0 to 20. The participant used a 10-point Visual Analog Scale (VAS) to evaluate loss of sleep and the occurrence of pruritus averaged over the last 3 days where 0=None to Worst Imaginable. The sum of the 2 VAS scores was 0 to 20. The above measures were added together for a total possible SCORAD score of 0 (best) to 103 (worst). A negative percentage change indicates improvement.

**Measure:** Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score

**Time Frame:** Baseline (Day 0) to Day 28

**Description:** The investigator assessed four body regions: Head and neck, Upper extremities, Trunk including axillae and groin, and Lower extremities including buttocks. Each body region was scored based on BSA where 0=No involvement to 6=90-100%. Each body region was assessed for erythema, infiltration/papulation, excoriation and lichenification using a 4-point scale where 0=None to 3=Severe. EASI total score was determined by combining the individual scores for each of the 4 body regions. The total for each region was calculated by \[erythema + infiltration+ excoriation + lichenification \* area involvement \* a constant (constants Head and Neck=0.1, Upper Limbs=0.2, Trunk=0.3, Lower Limbs=0.4)\]. The EASI total score was determined by combining the individual scores for each of the 4 body regions for a total possible score of 0 (best) to 72 (worst). A negative percentage change indicates improvement.

**Measure:** Percentage Change From Baseline Eczema Area and Severity Index (EASI)

**Time Frame:** Baseline (Day 0) to Day 28

**Description:** The participant used a 10-point VAS to assess the occurrence of pruritus (itchy skin) over the last 3 days where 0= None to 10=Worst Imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.

**Measure:** Percentage Change From Baseline in Pruritus VAS Score

**Time Frame:** Baseline (Day 0) to Day 28

**Description:** The participant used a 10-point VAS to evaluate loss of sleep averaged over the last 3 days where 0= None to 10=Worst imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.

**Measure:** Percentage Change From Baseline in VAS Sleep Score

**Time Frame:** Baseline (Day 0) to Day 28

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (BSA) involvement
* Investigator Global Assessments (IGA) score of 2 or 3
* Body Mass Index (BMI) = 18 - 35 kg/m\^2
* Negative Pregnancy test for females

Exclusion Criteria:

* Treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoclonal antibody agents, within specific time period prior to dosing.
* Organ dysfunction or any clinically significant deviation from normal in vital signs, physical examinations, labs, and Electrocardiogram (ECG) findings
* Major surgery within 3 months of Screening
* Use of prescription drugs, sedative antihistamine, medical devices for treatment of atopic dermatitis (AD), and topical products containing urea and/or ceramides within 14 prior to dosing
* Excessive sun exposures, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to dosing

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** West Dundee

**Country:** United States

**Facility:** Dundee Dermatology

**State:** Illinois

**Zip:** 60118

**Location 2:**

**City:** Fort Gratiot

**Country:** United States

**Facility:** Hamzavi Dermatology

**State:** Michigan

**Zip:** 48059

**Location 3:**

**City:** New York

**Country:** United States

**Facility:** Skin Specialty Dermatology

**State:** New York

**Zip:** 10155

**Location 4:**

**City:** Raleigh

**Country:** United States

**Facility:** Wake Research Associates, LLC

**State:** North Carolina

**Zip:** 27612

**Location 5:**

**City:** Philadelphia

**Country:** United States

**Facility:** Paddington Testing Company, Inc

**State:** Pennsylvania

**Zip:** 19103

**Location 6:**

**City:** Calgary

**Country:** Canada

**Facility:** Kirk Barber Research

**State:** Alberta

**Zip:** T2G1B1CA

**Location 7:**

**City:** Edmonton

**Country:** Canada

**Facility:** Stratica Medical Inc

**State:** Alberta

**Zip:** T5K 1X3

**Location 8:**

**City:** Markham

**Country:** Canada

**Facility:** Lynderm Research Inc

**State:** Ontario

**Zip:** L3P 1X2

**Location 9:**

**City:** Richmond Hill

**Country:** Canada

**Facility:** The Center for Dermatology / Institution

**State:** Ontario

**Zip:** L4B 1A5

**Location 10:**

**City:** Windsor

**Country:** Canada

**Facility:** Windsor Clinical Research Inc

**State:** Ontario

**Zip:** N8W 5L7

**Location 11:**

**City:** Drummondville

**Country:** Canada

**Facility:** Dr Isabelle Delorme Inc

**State:** Quebec

**Zip:** J2B 5L4

**Location 12:**

**City:** Montreal

**Country:** Canada

**Facility:** Innovaderm Research

**State:** Quebec

**Zip:** H2K4L5

#### Overall Officials

**Official 1:**

**Affiliation:** Allergan

**Name:** Christy Harutunian

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Czarnowicki T, Dohlman AB, Malik K, Antonini D, Bissonnette R, Chan TC, Zhou L, Wen HC, Estrada Y, Xu H, Bryson C, Shen J, Lala D, Ma'ayan A, McGeehan G, Gregg R, Guttman-Yassky E. Effect of short-term liver X receptor activation on epidermal barrier features in mild to moderate atopic dermatitis: A randomized controlled trial. Ann Allergy Asthma Immunol. 2018 Jun;120(6):631-640.e11. doi: 10.1016/j.anai.2018.03.013. Epub 2018 Mar 19.

**PMID:** 29567358

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000012873

- Term: Skin Diseases, Genetic

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000017443

- Term: Skin Diseases, Eczematous

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7067

- Name: Dermatitis

- Relevance: HIGH

- As Found: Dermatitis

- ID: M7655

- Name: Eczema

- Relevance: LOW

- As Found: Unknown

- ID: M7071

- Name: Dermatitis, Atopic

- Relevance: HIGH

- As Found: Dermatitis, Atopic

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15676

- Name: Skin Diseases, Genetic

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M19712

- Name: Skin Diseases, Eczematous

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003876

- Term: Dermatitis, Atopic

- ID: D000003872

- Term: Dermatitis

### Intervention Browse Module - Ancestors

- ID: D000018685

- Term: Anesthetics, Inhalation

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M8134

- Name: Ether

- Relevance: HIGH

- As Found: Brainstem

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M20765

- Name: Anesthetics, Inhalation

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000004986

- Term: Ether

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.

#### Event Groups

**Group ID:** EG000

**Title:** VTP- 38543 0.05%

**Deaths Num At Risk:** 20

**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.

**ID:** EG000

**Other Num Affected:** 10

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** VTP- 38543 0.05%

**Group ID:** EG001

**Title:** VTP- 38543 0.15%

**Deaths Num At Risk:** 19

**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.

**ID:** EG001

**Other Num Affected:** 12

**Other Num at Risk:** 19

**Serious Number At Risk:** 19

**Title:** VTP- 38543 0.15%

**Group ID:** EG002

**Title:** Vehicle Without Transcutol®P

**Deaths Num At Risk:** 20

**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.

**ID:** EG002

**Other Num Affected:** 12

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Vehicle Without Transcutol®P

**Group ID:** EG003

**Title:** VTP-38543 1%

**Deaths Num At Risk:** 24

**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.

**ID:** EG003

**Other Num Affected:** 8

**Other Num at Risk:** 24

**Serious Number At Risk:** 24

**Title:** VTP-38543 1%

**Group ID:** EG004

**Title:** Vehicle With Transcutol®P

**Deaths Num At Risk:** 20

**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.

**ID:** EG004

**Other Num Affected:** 6

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Vehicle With Transcutol®P

**Frequency Threshold:** 0

#### Other Events

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Hypothyroidism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Tooth impacted

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Application site pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Application site pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Administration site pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

**Term:** Post procedural infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

**Term:** Procedural dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 18.1

**Term:** Arthropod bite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 18.1

**Term:** Post procedural contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 18.1

**Term:** Sunburn

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 18.1

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

**Term:** Blood creatine phosphokinase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Musculoskeletal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Dermatitis atopic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Eczema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Urticaria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

**Term:** Application site reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Ligament sprain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 18.1

**Term:** Chest discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Dry eye

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Body tinea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

**Term:** Otitis media acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

**Time Frame:** First dose of study drug to the last visit (Up to Day 35)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Group ID:** BG001

**Value:** 19

**Group ID:** BG002

**Value:** 20

**Group ID:** BG003

**Value:** 24

**Group ID:** BG004

**Value:** 20

**Group ID:** BG005

**Value:** 103

**Units:** Participants

### Group

**ID:** BG000

**Title:** VTP- 38543 0.05%

**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.

### Group

**ID:** BG001

**Title:** VTP- 38543 0.15%

**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.

### Group

**ID:** BG002

**Title:** Vehicle Without Transcutol®P

**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.

### Group

**ID:** BG003

**Title:** VTP-38543 1%

**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.

### Group

**ID:** BG004

**Title:** Vehicle With Transcutol®P

**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.

### Group

**ID:** BG005

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 15.79

**Value:** 36.2

#### Measurement

**Group ID:** BG001

**Spread:** 13.39

**Value:** 36.8

#### Measurement

**Group ID:** BG002

**Spread:** 11.59

**Value:** 30.8

#### Measurement

**Group ID:** BG003

**Spread:** 10.51

**Value:** 35.7

#### Measurement

**Group ID:** BG004

**Spread:** 11.73

**Value:** 30.9

#### Measurement

**Group ID:** BG005

**Spread:** 12.67

**Value:** 34.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 14

#### Measurement

**Group ID:** BG004

**Value:** 9

#### Measurement

**Group ID:** BG005

**Value:** 55

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 12

#### Measurement

**Group ID:** BG003

**Value:** 10

#### Measurement

**Group ID:** BG004

**Value:** 11

#### Measurement

**Group ID:** BG005

**Value:** 48

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
**Population Description:** Safety population included randomized participants who received at least one dose of study medication.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** clinicaltrials@allergan.com
**Organization:** Allergan
**Phone:** 714-246-4500
**Title:** Therapeutic Area, Head
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.16
- **Upper Limit:** 
- **Value:** 0.546
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.175
- **Upper Limit:** 
- **Value:** 0.221
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.29
- **Upper Limit:** 
- **Value:** 2.34
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.35
- **Upper Limit:** 
- **Value:** 2.81
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.68
- **Upper Limit:** 
- **Value:** 2.28
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 12.7
- **Upper Limit:** 
- **Value:** 13.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 9
- **Value:** 5.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 9
- **Value:** 9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 9
- **Value:** 4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 24
- **Value:** 6.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 9
- **Value:** 4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.23
- **Upper Limit:** 
- **Value:** 2.27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.41
- **Upper Limit:** 
- **Value:** 1.35
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 28.2
- **Upper Limit:** 
- **Value:** 20.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 257
- **Upper Limit:** 
- **Value:** 129
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 77.5
- **Upper Limit:** 
- **Value:** 104
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 798
- **Upper Limit:** 
- **Value:** 720
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.23
- **Upper Limit:** 
- **Value:** 2.27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.41
- **Upper Limit:** 
- **Value:** 1.35
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 28.2
- **Upper Limit:** 
- **Value:** 20.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 44.8
- **Upper Limit:** 
- **Value:** 23.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18.2
- **Upper Limit:** 
- **Value:** 22.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 144
- **Upper Limit:** 
- **Value:** 144
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** t1/2 was not achieved at Day 0.
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** t1/2 was not achieved at Day 0.
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** t1/2 was not achieved at Day 0.
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 14.5
- **Upper Limit:** 
- **Value:** 58.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12.2
- **Upper Limit:** 
- **Value:** 47.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 349
- **Upper Limit:** 
- **Value:** 246
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 29.233
- **Upper Limit:** 
- **Value:** -39.09
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 52.978
- **Upper Limit:** 
- **Value:** -9.46
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 55.588
- **Upper Limit:** 
- **Value:** -17.39
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 48.063
- **Upper Limit:** 
- **Value:** -9.44
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 29.398
- **Upper Limit:** 
- **Value:** -28.51
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25.36
- **Upper Limit:** 
- **Value:** -12.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 34.96
- **Upper Limit:** 
- **Value:** -16.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 32.46
- **Upper Limit:** 
- **Value:** -19.4
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 34.79
- **Upper Limit:** 
- **Value:** -6.1
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 20.47
- **Upper Limit:** 
- **Value:** -13.2
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 30.1085
- **Upper Limit:** 
- **Value:** -23.473
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 34.7270
- **Upper Limit:** 
- **Value:** -17.300
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 35.6572
- **Upper Limit:** 
- **Value:** -24.453
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 32.2743
- **Upper Limit:** 
- **Value:** -14.483
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 26.0370
- **Upper Limit:** 
- **Value:** -18.630
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 29.832
- **Upper Limit:** 
- **Value:** -36.26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 66.519
- **Upper Limit:** 
- **Value:** -9.16
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 46.549
- **Upper Limit:** 
- **Value:** -26.99
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 58.819
- **Upper Limit:** 
- **Value:** -12.52
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 36.323
- **Upper Limit:** 
- **Value:** -27.10
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 112.105
- **Upper Limit:** 
- **Value:** 4.20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 48.771
- **Upper Limit:** 
- **Value:** -20.07
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 47.715
- **Upper Limit:** 
- **Value:** -26.75
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 42.232
- **Upper Limit:** 
- **Value:** -25.80
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 54.612
- **Upper Limit:** 
- **Value:** -34.68
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 61.845
- **Upper Limit:** 
- **Value:** -29.40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 78.382
- **Upper Limit:** 
- **Value:** -19.74
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 113.782
- **Upper Limit:** 
- **Value:** 2.73
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 53.672
- **Upper Limit:** 
- **Value:** -29.98
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 39.259
- **Upper Limit:** 
- **Value:** -30.85
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population included randomized participants who received at least one dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 35
**Title:** Number of Participants With Treatment-related Adverse Events (AEs)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 2
**Description:** Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population included randomized participants who received at least one dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 35
**Title:** Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 3
**Description:** Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population included randomized participants who received at least one dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 35
**Title:** Number of Participants With Clinically Significant Changes in Vital Signs
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 4
**Description:** A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population included randomized participants who received at least one dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 35
**Title:** Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 5
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic (PK) population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Title:** Maximum Plasma Concentration (Cmax) for VTP-38543-001
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** VTP-38543 1%
#### Outcome Measure 6
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Title:** Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
**Type:** SECONDARY
**Unit of Measure:** hour
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** VTP-38543 1%
#### Outcome Measure 7
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Title:** Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
**Type:** SECONDARY
**Unit of Measure:** ng*hr/mL
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** VTP-38543 1%
#### Outcome Measure 8
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Title:** Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
**Type:** SECONDARY
**Unit of Measure:** ng*hr/mL
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** VTP-38543 1%
#### Outcome Measure 9
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** PK Population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Title:** Elimination Half-life (t½) for VTP-38543
**Type:** SECONDARY
**Unit of Measure:** hour
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** VTP-38543 1%
#### Outcome Measure 10
**Description:** Percent BSA was estimated using the palmar surface of the participant's hand up to the proximal interphalangeal joint, including the thumb, to approximate 1% of the participant's BSA. The overall BSA affected by atopic dermatitis was evaluated from 0 to 100% and divided by 5 for a maximum of 20. A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Modified intent-to-treat (mITT) population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline in Total Body Surface Area (BSA)
**Type:** SECONDARY
**Unit of Measure:** percentage change in total BSA
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 11
**Description:** The investigator assessed the participant's atopic dermatitis using the 5-point IGA where 0=clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting) to 4=Severe disease (Deep/bright red erythema with severe induration/papulation with oozing/crusting). A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline in Investigator Global Assessments (IGA) Score
**Type:** SECONDARY
**Unit of Measure:** percentage change in IGA score
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 12
**Description:** The investigator assessed severity of atopic dermatitis (AD) using scoring atopic dermatitis (SCORAD) score obtained from different individual scales. 6-items: erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness were graded on a 4-point scale where 0=Absent to 3=Severe. The individual scores were added together to get a score of 0 to 18 that was multiplied by 3.5 for a score of 0 to 63. The overall BSA affected by AD (0 to 100 %) was divided by 5 for a score 0 to 20. The participant used a 10-point Visual Analog Scale (VAS) to evaluate loss of sleep and the occurrence of pruritus averaged over the last 3 days where 0=None to Worst Imaginable. The sum of the 2 VAS scores was 0 to 20. The above measures were added together for a total possible SCORAD score of 0 (best) to 103 (worst). A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
**Type:** SECONDARY
**Unit of Measure:** percentage change in SCORAD score
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 13
**Description:** The investigator assessed four body regions: Head and neck, Upper extremities, Trunk including axillae and groin, and Lower extremities including buttocks. Each body region was scored based on BSA where 0=No involvement to 6=90-100%. Each body region was assessed for erythema, infiltration/papulation, excoriation and lichenification using a 4-point scale where 0=None to 3=Severe. EASI total score was determined by combining the individual scores for each of the 4 body regions. The total for each region was calculated by \[erythema + infiltration+ excoriation + lichenification \* area involvement \* a constant (constants Head and Neck=0.1, Upper Limbs=0.2, Trunk=0.3, Lower Limbs=0.4)\]. The EASI total score was determined by combining the individual scores for each of the 4 body regions for a total possible score of 0 (best) to 72 (worst). A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline Eczema Area and Severity Index (EASI)
**Type:** SECONDARY
**Unit of Measure:** percentage change in EASI
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 14
**Description:** The participant used a 10-point VAS to assess the occurrence of pruritus (itchy skin) over the last 3 days where 0= None to 10=Worst Imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline in Pruritus VAS Score
**Type:** SECONDARY
**Unit of Measure:** percentage change in pruritis VAS score
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 15
**Description:** The participant used a 10-point VAS to evaluate loss of sleep averaged over the last 3 days where 0= None to 10=Worst imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline in VAS Sleep Score
**Type:** SECONDARY
**Unit of Measure:** percentage change in VAS sleep score
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
### Participant Flow Module
#### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** FG000
**Title:** VTP- 38543 0.05%
#### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** FG001
**Title:** VTP- 38543 0.15%
#### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** FG002
**Title:** Vehicle Without Transcutol®P
#### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** FG003
**Title:** VTP-38543 1%
#### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** FG004
**Title:** Vehicle With Transcutol®P
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 3
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
##### Withdraw
**Type:** Inability to Comply with the Protocol
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Other Miscellaneous Reasons
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 20
##### Milestone
**Type:** Received Study Drug (Safety Population)
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 16
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 19
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 19
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 1
**Has Results:** True