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Split-Face Application of Active for Solar Elastosis

N/A
Waitlist Available
Led By Jay Burns, MD
Research Sponsored by Revision Skincare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

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).

Eligible Conditions
  • Solar Elastosis
  • Wrinkles
  • Loose Skin

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Adverse Events
Investigator Tolerability
Subject Tolerability
Secondary study objectives
Self-Assessment Questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Split-Face Application of ActiveExperimental Treatment4 Interventions
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.
Group II: Split-Face Application of ComparatorActive Control4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hybrid Fractional Laser
2018
N/A
~170

Find a Location

Who is running the clinical trial?

Revision SkincareLead Sponsor
11 Previous Clinical Trials
412 Total Patients Enrolled
8 Trials studying Solar Elastosis
293 Patients Enrolled for Solar Elastosis
Jay Burns, MDPrincipal InvestigatorResurrect Skin MD
1 Previous Clinical Trials
30 Total Patients Enrolled
James Namnoum, MDPrincipal InvestigatorAYA™ Medical Spa
~5 spots leftby Sep 2025
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