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

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).

Study Overview

• Status: Completed
• Conditions: Wrinkle; Skin Laxity; Photoaging
• Intervention / Treatment: Procedure: Hybrid Fractional Laser; Other: Facial Cleanser; Other: Facial Moisturizer; Other: Sunscreen

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).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30305
      • AYA™ Medical Spa
  • Texas
    • Dallas, Texas, United States, 75225
      • Resurrect Skin MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Split-Face Application of Active; 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; 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 Names: HALO™ laser treatment; 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 Names: Gentle Cleansing Lotion, Revision Skincare; 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.; Other Names: Aveeno Positively Mineral Sensitive Skin with sun protection factor (SPF) 40+
Active Comparator: Split-Face Application of 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; 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 Names: HALO™ laser treatment; 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 Names: Gentle Cleansing Lotion, Revision Skincare; 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.; Other Names: Aveeno Positively Mineral Sensitive Skin with sun protection factor (SPF) 40+

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; = Mild; = Moderate; = 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; = Mild; = Moderate; = Severe	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Assessment Questionnaire	A change in response values at days 1, 5, and 7 compared to post-procedure/post-product application response values indicates an improvement. Baseline responses will be set to post-procedure/post-product application. Subjects are asked to rate statements based on a scoring system ranging from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement / question being asked.	7 days

Collaborators and Investigators

• Sponsor: Revision Skincare
• Investigators: Principal Investigator: Jay Burns, MD, Resurrect Skin MD; Principal Investigator: James Namnoum, MD, AYA™ Medical Spa

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Post-Procedure; Hybrid Fractional Laser
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa; Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: RS-2021-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes