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

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).

Conditions

• Photoaging
• Wrinkle
• Skin Laxity

Interventions

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.

Sponsors & Collaborators

• Revision Skincare

  lead INDUSTRY

Principal Investigators

• Jay Burns, MD · Resurrect Skin MD

• James Namnoum, MD · AYA™ Medical Spa

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-14

Primary Completion

2022-07-01

Completion

2022-07-01

FDA Device

Yes

Countries

• United States

Study Locations