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

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06436261
• Other study ID #: RS-2021-03
• Status: Completed
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2024
• Source: Revision Skincare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Photoaging
• Skin Laxity
• Wrinkle

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
United States	AYA™ Medical Spa	Atlanta	Georgia
United States	Resurrect Skin MD	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Revision Skincare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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