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

Revision Skincare

Status: Completed

Conditions: Skin Laxity; Photoaging; Wrinkle

Treatments: Other: Sunscreen; Other: Facial Moisturizer; Procedure: Hybrid Fractional Laser; Other: Facial Cleanser

Study type: Interventional

Funder types: Industry

Identifiers

NCT06436261

RS-2021-03

Details and patient eligibility

About

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).

Full 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).

Enrollment: 20 patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Split-Face Application of Active

Experimental group

Description:

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.

Treatment:

Other: Facial Cleanser

Procedure: Hybrid Fractional Laser

Other: Facial Moisturizer

Other: Sunscreen

Split-Face Application of Comparator

Active Comparator group

Description:

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.

Treatment:

Other: Facial Cleanser

Procedure: Hybrid Fractional Laser

Other: Facial Moisturizer

Other: Sunscreen