## Protocol Section
### Identification Module
**NCT ID:** NCT01189279

**Brief Title:** Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia

#### Organization Study ID Info
**ID:** 192024-053
#### Organization
**Class:** INDUSTRY
**Full Name:** Allergan
### Status Module
#### Completion Date
**Date:** 2011-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-08-30

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-06-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2013-08-30

**Type:** ESTIMATED

**Results First Submit Date:** 2013-06-24

**Results First Submit QC Date:** 2013-06-24

#### Start Date
**Date:** 2010-10

**Status Verified Date:** 2013-06

#### Study First Post Date
**Date:** 2010-08-26
**Type:** ESTIMATED
**Study First Submit Date:** 2010-08-25
**Study First Submit QC Date:** 2010-08-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Allergan

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.

### Conditions Module

**Conditions:**

- Alopecia

- Alopecia, Androgenetic

- Baldness

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 42

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.

**Intervention Names:**

- Drug: bimatoprost Formulation A

**Label:** Part 1: bimatoprost Formulation A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.

**Intervention Names:**

- Drug: bimatoprost Formulation B

**Label:** Part 1: bimatoprost Formulation B

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

**Intervention Names:**

- Drug: bimatoprost Formulation C

**Label:** Part 2: bimatoprost Formulation C

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Part 1: bimatoprost Formulation A

**Description:** bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.

**Name:** bimatoprost Formulation A

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Part 1: bimatoprost Formulation B

**Description:** bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.

**Name:** bimatoprost Formulation B

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Part 2: bimatoprost Formulation C

**Description:** bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

**Name:** bimatoprost Formulation C

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.

**Measure:** Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost

**Time Frame:** Day 1

**Description:** Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.

**Measure:** Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost

**Time Frame:** 17 Days

#### Secondary Outcomes

**Description:** An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T \[measured in milliseconds (ms)\], as well as the heart rate \[measured in beats per minute (bpm)\]. Clinically significant abnormal results include maximum post-treatment QTcB\>500 ms, maximum post-treatment QTcF\>500 ms, maximum post-treatment QT interval \>500 ms, PR interval 25% increase from baseline and \>200 ms, QRS interval 25% increase from baseline and \>100 ms, heart rate 25% increase from baseline and \>100 bpm, and heart rate 25% decrease from baseline and \<50 bpm.

**Measure:** Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings

**Time Frame:** 17 Days

**Description:** Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms.

**Measure:** Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment

**Time Frame:** Baseline, 20 Days

**Description:** Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms.

**Measure:** Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment

**Time Frame:** Baseline, 20 Days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Males with moderate male-pattern baldness (androgenic alopecia)
* Females with moderate female pattern hair loss
* Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products

Exclusion Criteria:

* Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females)
* Use of bimatoprost or other prostaglandin analogs within 3 months
* Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months
* Any prior hair growth procedures (eg, hair transplant or laser)
* Blood donation or equivalent blood loss within 90 days
* History of alcohol or drug addiction

**Maximum Age:** 64 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tempe

**Country:** United States

**State:** Arizona

#### Overall Officials

**Official 1:**

**Affiliation:** Allergan

**Name:** Medical Director

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007039

- Term: Hypotrichosis

- ID: D000006201

- Term: Hair Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3846

- Name: Alopecia

- Relevance: HIGH

- As Found: Alopecia

- ID: M3847

- Name: Alopecia Areata

- Relevance: HIGH

- As Found: Alopecia

- ID: M10089

- Name: Hypotrichosis

- Relevance: LOW

- As Found: Unknown

- ID: M9293

- Name: Hair Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000505

- Term: Alopecia

- ID: D000000506

- Term: Alopecia Areata

### Intervention Browse Module - Ancestors

- ID: D000000959

- Term: Antihypertensive Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M473

- Name: Bimatoprost

- Relevance: HIGH

- As Found: Port

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069580

- Term: Bimatoprost

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Part 1: Bimatoprost Formulation A

**Description:** bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.

**ID:** EG000

**Other Num Affected:** 7

**Other Num at Risk:** 14

**Serious Number At Risk:** 14

**Title:** Part 1: Bimatoprost Formulation A

**Group ID:** EG001

**Title:** Part 1: Bimatoprost Formulation B

**Description:** bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.

**ID:** EG001

**Other Num Affected:** 6

**Other Num at Risk:** 14

**Serious Number At Risk:** 14

**Title:** Part 1: Bimatoprost Formulation B

**Group ID:** EG002

**Title:** Part 2: Bimatoprost Formulation C

**Description:** bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

**ID:** EG002

**Other Num Affected:** 1

**Other Num at Risk:** 14

**Serious Number At Risk:** 14

**Title:** Part 2: Bimatoprost Formulation C

**Frequency Threshold:** 5

#### Other Events

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 13.1

**Term:** Feeling Hot

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 13.1

**Term:** Myalgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA version 13.1

**Term:** Neck Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA version 13.1

**Term:** Rhinorrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA version 13.1

**Term:** Somnolence

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 13.1

**Term:** Application Site Folliculitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 13.1

**Term:** Papule

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA version 13.1

**Term:** Procedural Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA version 13.1

**Term:** Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA version 13.1

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 14

**Group ID:** BG001

**Value:** 14

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 42

**Units:** Participants

### Group

**ID:** BG000

**Title:** Part 1: Bimatoprost Formulation A

**Description:** bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.

### Group

**ID:** BG001

**Title:** Part 1: Bimatoprost Formulation B

**Description:** bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.

### Group

**ID:** BG002

**Title:** Part 2: Bimatoprost Formulation C

**Description:** bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 17

**Class Title:** <45 years

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 25

**Class Title:** 45 to 64 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 7

#### Measurement

**Group ID:** BG003

**Value:** 21

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 7

#### Measurement

**Group ID:** BG003

**Value:** 21

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## 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, Inc
**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
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.575
- **Upper Limit:** 
- **Value:** 0.552
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.11
- **Upper Limit:** 
- **Value:** 1.77
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.66
- **Upper Limit:** 
- **Value:** 5.58
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.60
- **Upper Limit:** 
- **Value:** 1.26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.66
- **Upper Limit:** 
- **Value:** 3.01
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 7.0
- **Upper Limit:** 
- **Value:** 10.1
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 20.238
- **Upper Limit:** 
- **Value:** 0.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23.460
- **Upper Limit:** 
- **Value:** 0.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 19.667
- **Upper Limit:** 
- **Value:** 0.0
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**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
**Title:** 
#### Outcome Measure 5
**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
**Title:** 
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**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
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Per Protocol: all subjects with no major protocol deviations
**Reporting Status:** POSTED
**Time Frame:** Day 1
**Title:** Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost
**Type:** PRIMARY
**Unit of Measure:** Picograms/Milliliter (pg/mL)
##### Group
**Description:** bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG000
**Title:** Part 1: Bimatoprost Formulation A
##### Group
**Description:** bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG001
**Title:** Part 1: Bimatoprost Formulation B
##### Group
**Description:** bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG002
**Title:** Part 2: Bimatoprost Formulation C
#### Outcome Measure 2
**Description:** Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Per Protocol: all subjects with no major protocol deviations
**Reporting Status:** POSTED
**Time Frame:** 17 Days
**Title:** Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost
**Type:** PRIMARY
**Unit of Measure:** Picograms/Milliliter (pg/mL)
##### Group
**Description:** bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG000
**Title:** Part 1: Bimatoprost Formulation A
##### Group
**Description:** bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG001
**Title:** Part 1: Bimatoprost Formulation B
##### Group
**Description:** bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG002
**Title:** Part 2: Bimatoprost Formulation C
#### Outcome Measure 3
**Description:** An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T \[measured in milliseconds (ms)\], as well as the heart rate \[measured in beats per minute (bpm)\]. Clinically significant abnormal results include maximum post-treatment QTcB\>500 ms, maximum post-treatment QTcF\>500 ms, maximum post-treatment QT interval \>500 ms, PR interval 25% increase from baseline and \>200 ms, QRS interval 25% increase from baseline and \>100 ms, heart rate 25% increase from baseline and \>100 bpm, and heart rate 25% decrease from baseline and \<50 bpm.
**Parameter Type:** NUMBER
**Population Description:** Safety Population: all subjects who received at least 1 dose of study medication
**Reporting Status:** POSTED
**Time Frame:** 17 Days
**Title:** Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings
**Type:** SECONDARY
**Unit of Measure:** Percentage of Patients
##### Group
**Description:** bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG000
**Title:** Part 1: Bimatoprost Formulation A
##### Group
**Description:** bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG001
**Title:** Part 1: Bimatoprost Formulation B
##### Group
**Description:** bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG002
**Title:** Part 2: Bimatoprost Formulation C
#### Outcome Measure 4
**Description:** Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms.
**Parameter Type:** NUMBER
**Population Description:** Safety Population: all subjects who received at least 1 dose of study medication
**Reporting Status:** POSTED
**Time Frame:** Baseline, 20 Days
**Title:** Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment
**Type:** SECONDARY
**Unit of Measure:** Patients
##### Group
**Description:** bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG000
**Title:** Part 1: Bimatoprost Formulation A
##### Group
**Description:** bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG001
**Title:** Part 1: Bimatoprost Formulation B
##### Group
**Description:** bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG002
**Title:** Part 2: Bimatoprost Formulation C
#### Outcome Measure 5
**Description:** Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms.
**Parameter Type:** NUMBER
**Population Description:** Safety Population: all subjects who received at least 1 dose of study medication
**Reporting Status:** POSTED
**Time Frame:** Baseline, 20 Days
**Title:** Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment
**Type:** SECONDARY
**Unit of Measure:** Patients
##### Group
**Description:** bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG000
**Title:** Part 1: Bimatoprost Formulation A
##### Group
**Description:** bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG001
**Title:** Part 1: Bimatoprost Formulation B
##### Group
**Description:** bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** OG002
**Title:** Part 2: Bimatoprost Formulation C
### Participant Flow Module
#### Group
**Description:** bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** FG000
**Title:** Part 1: Bimatoprost Formulation A
#### Group
**Description:** bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** FG001
**Title:** Part 1: Bimatoprost Formulation B
#### Group
**Description:** bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
**ID:** FG002
**Title:** Part 2: Bimatoprost Formulation C
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 14
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 13
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 1
**Pre-Assignment Details:** Part 1 of the study was double-blind, followed by Part 2 which was open-label. No patients enrolled in Part 1 were enrolled in Part 2 of the study.
**Has Results:** True