Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation

NCT ID: NCT06366503

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2023-12-29

Brief Summary

This randomized, single-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 fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point Modified Griffiths' scale). Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures. This is a cosmetic study with a FDA-regulated device.

A total of 22 healthy female subjects completed the study.

Detailed Description

This randomized, single-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 fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point Modified Griffiths' 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) and pain over the course of the study. Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures.

A 14-day washout period was required of all subjects prior to CO2 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, 7, and 14 post-procedure. Pain evaluations were completed by subjects using the 11-point Wong Baker Faces® Pain Rating scale post-procedure, post-procedure/post-product application, and days 1, 3, 5, 7, and 14 post-procedure.

In addition, efficacy evaluation using the Modified Griffiths' scale was performed at screening, pre-procedure, and days 1, 3, 5, 7, and 14 post-procedure. Self-assessment questionnaires were completed by subjects post-procedure/post-product application and days 1, 3, and 14 post-procedure. Clinical photography was completed at all timepoints (screening to day 14 post-procedure).

A total of 22 subjects completed study participation.

Conditions

Photoaging; Wrinkle; Skin Laxity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Split-Face Application of Active (Experimental)

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 face (including upper eyelid), jawline, and neck. The product was labelled with Right or Left depending on split-face randomization.

Study duration: 28 days. Active Post-Procedure Cream duration 14-days.

Group Type: EXPERIMENTAL

Fractional Ablative CO2 Laser

Intervention Type: PROCEDURE

A fractional ablative DEKA SmartXide Tetra CO2 laser treatment was performed after a 14-day washout period. Subjects were numbed for 1 hour prior to procedure with topical numbing cream (lidocaine 23%, tetracaine 7%). The global face was treated with a single pass. Treatment parameters include power 20 W, spacing 500 um (13% density), Dwell time 1200 us DEKA pulse mode, spray mode on.

Facial Cleanser

Intervention Type: OTHER

Facial cleanser was to be used by subjects twice daily during the 14-day washout period and three times daily during the 14-day post-procedure timeline.

Facial Moisturizer

Intervention Type: OTHER

A bland facial moisturizer was to be used by subjects twice daily during the 14-day washout period and three times daily between day 3 and 14 post-procedure. Two pumps were to be applied to the face (avoiding the upper eyelid) after applying the active and comparator.

Sunscreen

Intervention Type: OTHER

During the 14-day washout period, a bland sunscreen was to be used by subjects in the morning after cleansing and facial moisturizer application with reapplications as needed throughout the day per FDA recommendations. For days 3-14 post-procedure, the bland sunscreen was to be used daily by subjects in the morning and afternoon after cleansing, split-face application of the active post-procedure cream and comparator anhydrous formulation, and facial moisturizer application.

Split-Face Application of Comparator

COMPARATOR:

Dosage Form: anhydrous formulation.

Comparator Anhydrous Formulation Frequency of Dosage: Three times daily (morning, afternoon, and evening). Subjects were asked to apply on the face (including upper eyelid), jawline, and neck. The product was labelled with Right or Left depending on split-face randomization.

Study duration: 28 days. Comparator duration 14-days.

Group Type: ACTIVE_COMPARATOR

Fractional Ablative CO2 Laser

Intervention Type: PROCEDURE

A fractional ablative DEKA SmartXide Tetra CO2 laser treatment was performed after a 14-day washout period. Subjects were numbed for 1 hour prior to procedure with topical numbing cream (lidocaine 23%, tetracaine 7%). The global face was treated with a single pass. Treatment parameters include power 20 W, spacing 500 um (13% density), Dwell time 1200 us DEKA pulse mode, spray mode on.

Facial Cleanser

Intervention Type: OTHER

Facial cleanser was to be used by subjects twice daily during the 14-day washout period and three times daily during the 14-day post-procedure timeline.

Facial Moisturizer

Intervention Type: OTHER

A bland facial moisturizer was to be used by subjects twice daily during the 14-day washout period and three times daily between day 3 and 14 post-procedure. Two pumps were to be applied to the face (avoiding the upper eyelid) after applying the active and comparator.

Sunscreen

Intervention Type: OTHER

During the 14-day washout period, a bland sunscreen was to be used by subjects in the morning after cleansing and facial moisturizer application with reapplications as needed throughout the day per FDA recommendations. For days 3-14 post-procedure, the bland sunscreen was to be used daily by subjects in the morning and afternoon after cleansing, split-face application of the active post-procedure cream and comparator anhydrous formulation, and facial moisturizer application.

Basic Ointment

Intervention Type: OTHER

The basic ointment was used only on the comparator side for three days (72 hours) post-procedure. This was a requirement of the comparator anhydrous formulation.

Interventions

Fractional Ablative CO2 Laser

A fractional ablative DEKA SmartXide Tetra CO2 laser treatment was performed after a 14-day washout period. Subjects were numbed for 1 hour prior to procedure with topical numbing cream (lidocaine 23%, tetracaine 7%). The global face was treated with a single pass. Treatment parameters include power 20 W, spacing 500 um (13% density), Dwell time 1200 us DEKA pulse mode, spray mode on.

Intervention Type: PROCEDURE

Facial Cleanser

Facial cleanser was to be used by subjects twice daily during the 14-day washout period and three times daily during the 14-day post-procedure timeline.

Intervention Type: OTHER

Facial Moisturizer

A bland facial moisturizer was to be used by subjects twice daily during the 14-day washout period and three times daily between day 3 and 14 post-procedure. Two pumps were to be applied to the face (avoiding the upper eyelid) after applying the active and comparator.

Intervention Type: OTHER

Sunscreen

During the 14-day washout period, a bland sunscreen was to be used by subjects in the morning after cleansing and facial moisturizer application with reapplications as needed throughout the day per FDA recommendations. For days 3-14 post-procedure, the bland sunscreen was to be used daily by subjects in the morning and afternoon after cleansing, split-face application of the active post-procedure cream and comparator anhydrous formulation, and facial moisturizer application.

Intervention Type: OTHER

Basic Ointment

The basic ointment was used only on the comparator side for three days (72 hours) post-procedure. This was a requirement of the comparator anhydrous formulation.

Intervention Type: OTHER

Other Intervention Names

DEKA SmartXide Tetra CO2 laser treatment; Gentle Foaming Cleanser, Revision Skincare; Neutrogena Sheer Zinc SPF 50; Vanicream Moisturizing Ointment

Eligibility Criteria

Inclusion Criteria

• Healthy female subjects 35-65 years of age
• Fitzpatrick Skin Type I to III
• Any race or ethnicity
• Moderate to Severe Overall Photodamage (global face) (score of 4 to 9 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, microdermabrasion, hydro dermabrasion or anti-aging facial within 1 month; non-ablative laser (including IPL) or non-ablative fractional laser resurfacing of the face within 6 months; ablative laser resurfacing of the face within 12 months.
• Not willing to discontinue active topical facial products for 14 days prior to the Baseline Visit

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Revision Skincare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan Weir, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Dermatology Group

Locations

The Dermatology Group

Blue Ash, Ohio, United States

Countries

United States

Other Identifiers

RS-2023-05

Identifier Type: -

Identifier Source: org_study_id