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
- Interventions
- Procedure: Fractional Ablative CO2 LaserOther: Facial CleanserOther: Facial MoisturizerOther: SunscreenOther: Basic Ointment
- 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
- Arm && Interventions
Group Intervention Description Split-Face Application of Active (Experimental) Fractional Ablative CO2 Laser 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. Split-Face Application of Active (Experimental) Facial Moisturizer 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. Split-Face Application of Comparator Facial Cleanser 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. Split-Face Application of Active (Experimental) Facial Cleanser 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. Split-Face Application of Comparator Facial Moisturizer 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. Split-Face Application of Active (Experimental) Sunscreen 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. Split-Face Application of Comparator Basic Ointment 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. Split-Face Application of Comparator Fractional Ablative CO2 Laser 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. Split-Face Application of Comparator Sunscreen 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.
- 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