Photoaging, Wrinkle, Skin Laxity
Conditions
Keywords
Post-Procedure, Hybrid Fractional Laser
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).
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).
Interventions
PROCEDUREHybrid 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.
OTHERFacial 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.
OTHERFacial 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).
OTHERSunscreen
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
Revision Skincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Randomized, Multi-Center, Double-Blinded, Split-Face, Controlled
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Tolerability | 7 days | 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 |
| Incidence of Adverse Events | 7 days | 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. |
| Subject Tolerability | 7 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Assessment Questionnaire | 7 days | 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. |
Countries
United States
Outcome results
None listed