Evaluation of the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Revision Skincare
Study ID
NCT07501000
Status
Completed

Conditions

  • Hyperpigmentation
  • Post Inflammatory Hyperpigmentation
  • Skin Ageing
  • Skin Roughness

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Brightening Treatment — OTHER
    Subjects will receive a brightening treatment at baseline, week 2, week 4, and week 6. At Baseline subjects will receive their 1st Brightening treatment (3 layers). At Visits 3, 4, and 5 (weeks 2, 4 and 6), subjects will receive 2nd, 3rd, and 4th Brightening Treatment (4, 5, and 5 Peel layers, respectively).

Study Details

A12-week single-center, open-label, clinical study is being conducted to assess the efficacy and tolerability of the Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global facial pigmentation due to sun exposure, blemishes, and/or procedures when applied by a clinician in a series of 4 sessions at 2-week intervals. The procedure in this clinical study will include the brightening treatment, retinol serum, and a post-procedure cream. The study visits include baseline, week 2, 6, and 12.

Key Dates

Start date
Oct 7, 2024
Status verified
Mar 2026
Primary completion
Jan 23, 2025
Completion
Jan 23, 2025

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Skincare Regimen
    7 day washout period skincare regimen: \- Gentle foaming Cleanser twice daily, vitamin C serum twice daily, and Broad-Spectrum Sunscreen SPF 50 once daily. 12-Week skincare regimen: Subjects will be provided with a Gentle Foaming Cleanser, Post Procedure Cream, Vitamin C Serum, and a Broad-Spectrum sunscreen SPF 50 for at home use. * Gentle Foaming Cleanser will be instructed to be used twice daily. * Post Procedure Cream will be instructed to be used twice daily on days 0, 1, and 2 post treatment. * Vitamin C Serum will be instructed to be used twice daily starting on Day 3 post treatment until the next clinic study visit. * Sunscreen SPF 50 will be used after application as the last step in the skin care regimen in the morning. Sunscreen to be reapplied if continuous sun exposure occurs.

Primary Outcome Measure

Measurement of Investigator Clinical Grading [ Time Frame: Baseline, weeks 2, 4, 6, and 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Skin Wellness DermatologyBirminghamAlabama35209-

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Skin Wellness Dermatology· Birmingham, AL

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