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

NCT06436261 | Completed FDA Device

• 1 other identifier: RS-2021-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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).

Conditions

Photoaging; Wrinkle; Skin Laxity

Keywords

Post-Procedure; Hybrid Fractional Laser

Outcome Measures

Primary Outcomes (3)

• Investigator Tolerability

  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. = Severe

  7 days

• Incidence of Adverse Events

  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.

  7 days

• Subject Tolerability

  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

  7 days

Secondary Outcomes (1)

• Self-Assessment Questionnaire

  7 days

Study Arms (2)

Split-Face Application of Active

EXPERIMENTAL

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.

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

Split-Face Application of Comparator

ACTIVE COMPARATOR

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.

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

Interventions

Hybrid Fractional Laser PROCEDURE

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.

Also known as: HALO™ laser treatment

Split-Face Application of Active; Split-Face Application of Comparator

Facial Cleanser OTHER

Subjects were to use the provided cleanser twice daily (morning and evening) during the 7-day washout period and 7-day post-procedure timeline.

Also known as: Gentle Cleansing Lotion, Revision Skincare

Split-Face Application of Active; Split-Face Application of Comparator

Facial Moisturizer OTHER

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).

Split-Face Application of Active; Split-Face Application of Comparator

Sunscreen OTHER

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.

Also known as: Aveeno Positively Mineral Sensitive Skin with sun protection factor (SPF) 40+

Split-Face Application of Active; Split-Face Application of Comparator

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Revision Skincare: lead

Study Sites (2)

AYA™ Medical Spa

Atlanta, Georgia, 30305, United States

Location

Resurrect Skin MD

Dallas, Texas, 75225, United States

Location

Related Publications (1)

• Weir NM, Burns AJ, Kononov T, Zahr AS. A Novel Neurocosmetic Postprocedure Cream for Optimal Recovery and Tolerability From Energy-Based Devices. Lasers Surg Med. 2025 Dec;57(10):788-798. doi: 10.1002/lsm.70078. Epub 2025 Nov 24.

  PMID: 41286587 DERIVED

MeSH Terms

Conditions

Cutis Laxa

Interventions

Sunscreening Agents; Sun Protection Factor

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Radiometry

Study Officials

• Jay Burns, MD

  Resurrect Skin MD

  PRINCIPAL INVESTIGATOR

• James Namnoum, MD

  AYA™ Medical Spa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects were randomly assigned to use the active post-procedure cream on one side of the face and the comparator moisturizer on the opposite side of the face. The products were packaged in the same container and labelled post-procedure cream. This was a double-blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of efficacy or safety were blinded to the group during the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Multi-Center, Double-Blinded, Split-Face, Controlled

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: December 14, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

US (2)