Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Hybrid-Fractional Laser for Facial Rejuvenation
NCT ID: NCT06436261
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-12-14
2022-07-01
Brief Summary
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A total of 16 healthy female subjects completed the study (8 subjects at both sites).
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
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.
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
65 Years
FEMALE
Yes
Sponsors
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Revision Skincare
INDUSTRY
Responsible Party
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Principal Investigators
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Jay Burns, MD
Role: PRINCIPAL_INVESTIGATOR
Resurrect Skin MD
James Namnoum, MD
Role: PRINCIPAL_INVESTIGATOR
AYA™ Medical Spa
Locations
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AYA™ Medical Spa
Atlanta, Georgia, United States
Resurrect Skin MD
Dallas, Texas, United States
Countries
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Other Identifiers
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RS-2021-03
Identifier Type: -
Identifier Source: org_study_id
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