## Protocol Section
### Identification Module
**NCT ID:** NCT06436261

**Brief Title:** Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Hybrid-Fractional Laser for Facial Rejuvenation

**Official Title:** A Randomized, Multi-Center, Double-Blinded, Split-Face, Controlled Study Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Hybrid-Factional Laser for Facial Rejuvenation

#### Organization Study ID Info
**ID:** RS-2021-03
#### Organization
**Class:** INDUSTRY
**Full Name:** Revision Skincare
### Status Module
#### Completion Date
**Date:** 2022-07-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-07-01

**Type:** ACTUAL

#### Start Date
**Date:** 2021-12-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Revision Skincare

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This randomized, multi-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after hybrid-fractional laser treatment and for 7 days post-procedure with three times daily application in healthy female subjects aged 35-65 years with moderate to severe global face photodamage (score of 4 to 7 out of the 10-point Modified Griffiths' scale). Furthermore, this clinical trial compared the active post-procedure cream to a comparator moisturizer often paired with skin rejuvenation procedures. This is a cosmetic study with an FDA-regulated device.

A total of 16 healthy female subjects completed the study (8 subjects at both sites).

**Detailed Description:** This randomized, multi-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after hybrid-fractional laser treatment and for 7 days post-procedure with three times daily application in healthy female subjects aged 35-65 years with moderate to severe global face photodamage (score of 4 to 7 out of the 10-point modified Griffith's scale). The ability of the post-procedure cream to soothe skin and improve patient downtime post-procedure was investigated by evaluating tolerability parameters (erythema, edema, dryness, burning, itching, stinging) over the course of the study. Furthermore, this clinical trial compared the active post-procedure cream to a comparator moisturizer often paired with skin rejuvenation procedures.

A 7-day washout period was required of all subjects prior to hybrid-fractional laser treatment. Tolerability (investigator: erythema, edema, dryness; subject: burning, itching, stinging) and safety were assessed through grading at screening, pre-procedure, post-procedure, post-procedure/post-product application, and days 1, 3, 5, and 7 post-procedure.

In addition, efficacy evaluation using the Modified Griffiths' scale was performed at screening, pre-procedure, and day 7 post-procedure. Self-assessment questionnaires were completed by subjects post-procedure/post-product application and days 1, 5, and 7 post-procedure. Clinical photography was completed at screening, pre-procedure, post-procedure/post-product application, and days 1, 3, 5, and 7 post-procedure.

A total of 16 healthy female subjects completed the study (8 subjects at both sites).

### Conditions Module

**Conditions:**

- Photoaging

- Wrinkle

- Skin Laxity

**Keywords:**

- Post-Procedure

- Hybrid Fractional Laser

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized, Multi-Center, Double-Blinded, Split-Face, Controlled

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Subjects were randomly assigned to use the active post-procedure cream on one side of the face and the comparator moisturizer on the opposite side of the face.

The products were packaged in the same container and labelled post-procedure cream. This was a double-blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of efficacy or safety were blinded to the group during the study.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Active (Experimental) Post-Procedure Cream

Dosage Form: reverse emulsion (water in oil) cream containing bioactive ingredients, botanical actives, peptides, and antioxidants.

Frequency of Dosage: Three times daily (morning, afternoon, and evening). Subjects were asked to apply to the face, forehead, under eyes, cheeks, upper lips, chin, and nose. The product was labelled with Right or Left depending on split-face randomization.

Study Duration: 14 days. Active Post-Procedure Cream duration 14 days.

**Intervention Names:**

- Procedure: Hybrid Fractional Laser

- Other: Facial Cleanser

- Other: Facial Moisturizer

- Other: Sunscreen

**Label:** Split-Face Application of Active

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** COMPARATOR:

Dosage Form: moisturizer formulation

Comparator Moisturizer Frequency of Dosage: Three times daily (morning, afternoon, and evening). Subjects were asked to apply to the face, forehead, under eyes, cheeks, upper lips, chin, and nose. The product was labelled with Right or Left depending on split-face randomization.

Study Duration: 14 days. Comparator duration 14 days.

**Intervention Names:**

- Procedure: Hybrid Fractional Laser

- Other: Facial Cleanser

- Other: Facial Moisturizer

- Other: Sunscreen

**Label:** Split-Face Application of Comparator

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Split-Face Application of Active

- Split-Face Application of Comparator

**Description:** A hybrid fractional HALO™ laser treatment was performed after a 7-day washout period. Subjects were numbed for 30 minutes to 1 hour prior to the procedure with a topical numbing cream containing benzocaine, lidocaine, and/or tetracaine. After numbing was completed, patients received one full-face HALO™ laser treatment with settings 350/20/20.

**Name:** Hybrid Fractional Laser

**Other Names:**

- HALO™ laser treatment

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Split-Face Application of Active

- Split-Face Application of Comparator

**Description:** Subjects were to use the provided cleanser twice daily (morning and evening) during the 7-day washout period and 7-day post-procedure timeline.

**Name:** Facial Cleanser

**Other Names:**

- Gentle Cleansing Lotion, Revision Skincare

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Split-Face Application of Active

- Split-Face Application of Comparator

**Description:** Subjects were to use the provided bland facial moisturizer as follows:

WASHOUT PERIOD (7 days): After cleansing, 1-2 pumps were to be applied twice daily (morning and evening) to the full face avoiding the eye area

POST-PROCEDURE (7 days): After applying the Post-Procedure Cream and Active Comparator based on split-face randomization, the facial moisturizer was to be applied twice daily (morning and afternoon).

**Name:** Facial Moisturizer

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Split-Face Application of Active

- Split-Face Application of Comparator

**Description:** During the 7-day washout period and 7-day post-procedure timeline, subjects were to apply the provided basic sunscreen in the morning and afternoon after applying facial moisturizer. Sunscreen was to be reapplied as needed throughout the day per FDA recommendations.

**Name:** Sunscreen

**Other Names:**

- Aveeno Positively Mineral Sensitive Skin with sun protection factor (SPF) 40+

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in score of lack of significant change post-procedure/post-product application and days 1, 3, 5, and 7 post-procedure in comparison to immediately post-procedure indicates tolerability/safety of the test material.

A four-point scale will be used with a lower score indicating a better outcome:

0 = None

1. = Mild
2. = Moderate
3. = Severe

**Measure:** Investigator Tolerability

**Time Frame:** 7 days

**Description:** The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects, including immediately post-procedure and throughout the length of the study.

**Measure:** Incidence of Adverse Events

**Time Frame:** 7 days

**Description:** The subject tolerability endpoint will be Subject Tolerability Assessment of burning, itching, and stinging. A change in score of lack of significant change post-procedure/post-product application and days 1, 3, 5, and 7 post-procedure in comparison to immediately post-procedure indicates tolerability/safety of the test material.

A four-point scale will be used with a lower score indicating a better outcome:

0 = None

1. = Mild
2. = Moderate
3. = Severe

**Measure:** Subject Tolerability

**Time Frame:** 7 days

#### Secondary Outcomes

**Description:** A change in response values at days 1, 5, and 7 compared to post-procedure/post-product application response values indicates an improvement. Baseline responses will be set to post-procedure/post-product application. Subjects are asked to rate statements based on a scoring system ranging from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement / question being asked.

**Measure:** Self-Assessment Questionnaire

**Time Frame:** 7 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy female subjects 35-65 years of age
* Fitzpatrick Skin Type I to III
* Moderate to severe global face photodamage (score of 4 to 7 out of the 10-point Modified Griffiths' scale, where 0 = none and 9 = severe)
* No known medical conditions that, in the Investigator's opinion, may interfere with study participation.
* Willing to discontinue all active topical facial products and only use the assigned test products for the duration of the study.
* Female subjects of childbearing potential must be willing to use a form of birth control during the study.

Exclusion Criteria:

* Nursing, pregnant, or planning a pregnancy during this study.
* Having undergone a chemical peel, dermabrasion, or microneedling (mechanical and radiofrequency) in the last 6 months; laser resurfacing (ablative, fractional, non-ablative) in the last 12 months
* Not willing to discontinue active topical facial products for 7 days prior to the Baseline Visit

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 35 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Atlanta

**Country:** United States

**Facility:** AYA™ Medical Spa

**State:** Georgia

**Zip:** 30305

**Location 2:**

**City:** Dallas

**Country:** United States

**Facility:** Resurrect Skin MD

**State:** Texas

**Zip:** 75225

#### Overall Officials

**Official 1:**

**Affiliation:** Resurrect Skin MD

**Name:** Jay Burns, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** AYA™ Medical Spa

**Name:** James Namnoum, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012873

- Term: Skin Diseases, Genetic

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6692

- Name: Cutis Laxa

- Relevance: HIGH

- As Found: Skin Laxity

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

- 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: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1692

- Name: Cutis Laxa

- Relevance: HIGH

- As Found: Skin Laxity

### Condition Browse Module - Meshes

- ID: D000003483

- Term: Cutis Laxa

### Intervention Browse Module - Ancestors

- ID: D000011837

- Term: Radiation-Protective Agents

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000003879

- Term: Dermatologic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M16255

- Name: Sunscreening Agents

- Relevance: HIGH

- As Found: Gap

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: M16517

- Name: Tetracaine

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14684

- Name: Radiation-Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000013473

- Term: Sunscreening Agents

### Misc Info Module

- Version Holder: 2024-05-31
