Trials / Completed

CompletedNCT06436261

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

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 20 (actual)

Sponsor: Revision Skincare · Industry
Sex: Female
Age: 35 Years – 65 Years
Healthy volunteers: Accepted

Summary

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).

Conditions

Interventions

Type	Name	Description
PROCEDURE	Hybrid Fractional Laser	A hybrid fractional HALO™ laser treatment was performed after a 7-day washout period. Subjects were numbed for 30 minutes to 1 hour prior to the procedure with a topical numbing cream containing benzocaine, lidocaine, and/or tetracaine. After numbing was completed, patients received one full-face HALO™ laser treatment with settings 350/20/20.
OTHER	Facial Cleanser	Subjects were to use the provided cleanser twice daily (morning and evening) during the 7-day washout period and 7-day post-procedure timeline.
OTHER	Facial Moisturizer	Subjects were to use the provided bland facial moisturizer as follows: WASHOUT PERIOD (7 days): After cleansing, 1-2 pumps were to be applied twice daily (morning and evening) to the full face avoiding the eye area POST-PROCEDURE (7 days): After applying the Post-Procedure Cream and Active Comparator based on split-face randomization, the facial moisturizer was to be applied twice daily (morning and afternoon).
OTHER	Sunscreen	During the 7-day washout period and 7-day post-procedure timeline, subjects were to apply the provided basic sunscreen in the morning and afternoon after applying facial moisturizer. Sunscreen was to be reapplied as needed throughout the day per FDA recommendations.

Timeline

Start date: 2021-12-14
Primary completion: 2022-07-01
Completion: 2022-07-01
First posted: 2024-05-31
Last updated: 2024-05-31

Locations

2 sites across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT06436261. Inclusion in this directory is not an endorsement.