Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
- Conditions
- WrinklePhotoagingSkin Laxity
- Registration Number
- NCT06366503
- Lead Sponsor
- Revision Skincare
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 23
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events 14-days 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.
Investigator Tolerability 14 days The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in score or lack of significant change post product application, Day 1 (24 hours), Day 3, Day 5, Day 7, and Day 14 in comparison to baseline (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. = SevereSubject Tolerability 14 days The subject tolerability endpoint will be Subject Tolerability Assessment of burning, itching, and stinging. A change in score or lack of significant change post product application, Day 1 (24 hours), Day 3, Day 5, Day 7, and Day 14 in comparison to baseline (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
- Secondary Outcome Measures
Name Time Method Self-Assessment Questionnaire 14 days A change in response values at Day 1 (24 hours), Day 3, and Day 14 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 based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement / question being asked.
Trial Locations
- Locations (1)
The Dermatology Group
🇺🇸Blue Ash, Ohio, United States
The Dermatology Group🇺🇸Blue Ash, Ohio, United States