Clinical trial NCT06436261: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photoaging
Wrinkle
Skin Laxity
Keywords: Post-Procedure
Hybrid Fractional Laser
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
First posted: 2024-05-31
Enrollment: 20
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Multi-Center, Double-Blinded, Split-Face, Controlled
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Investigator Tolerability
timeFrame: 7 days
measure: Incidence of Adverse Events
timeFrame: 7 days
measure: Subject Tolerability
timeFrame: 7 days
Secondary outcomes:
measure: Self-Assessment Questionnaire
timeFrame: 7 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: AYA™ Medical Spa
state: Georgia
city: Dallas
country: United States
facility: Resurrect Skin MD
state: Texas
Study officials:
affiliation: Resurrect Skin MD
name: Jay Burns, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AYA™ Medical Spa
name: James Namnoum, MD
role: PRINCIPAL_INVESTIGATOR
References: