Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Hybrid-Fractional Laser for Facial Rejuvenation
- Conditions
- WrinklePhotoagingSkin Laxity
- Interventions
- Procedure: Hybrid Fractional LaserOther: Facial CleanserOther: Facial MoisturizerOther: Sunscreen
- Registration Number
- NCT06436261
- Lead Sponsor
- Revision Skincare
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Split-Face Application of Comparator Facial Cleanser 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. Split-Face Application of Comparator Sunscreen 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. Split-Face Application of Active Hybrid Fractional 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 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. Split-Face Application of Active 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 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. Split-Face Application of Active 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 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. Split-Face Application of Active 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 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. Split-Face Application of Comparator Hybrid Fractional Laser 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. Split-Face Application of Comparator Facial Moisturizer 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.
- Primary Outcome Measures
Name Time Method Investigator Tolerability 7 days 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. = SevereIncidence of Adverse Events 7 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.
Subject Tolerability 7 days 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
- Secondary Outcome Measures
Name Time Method Self-Assessment Questionnaire 7 days 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.
Trial Locations
- Locations (2)
AYAâ„¢ Medical Spa
🇺🇸Atlanta, Georgia, United States
Resurrect Skin MD
🇺🇸Dallas, Texas, United States