An interventional study of Brightening Treatment in Hyperpigmentation, Skin Ageing and Post Inflammatory Hyperpigmentation, sponsored by Revision Skincare. Completed at 1 site in United States. Open to female participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Revision Skincare · Not applicable, Interventional, and Other
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.
A 12-week, single-center, open-label, clinical case study evaluating the efficacy and tolerability of a Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global face pigmentation when applied by a clinician in a series of 4 sessions at 2-week intervals.
At Visit 1 (Screening, Day -7), subjects will review and sign an Informed Consent Form (ICF) and photography release form. Subjects will then be screened for eligibility, and qualified subjects will commence a 7-day pre-treatment skincare regimen and be scheduled for the baseline visit. Subjects will be provided with the Gentle Foaming Cleanser, Vitamin C Serum, and a Broad-Spectrum Sunscreen SPF 50 to be used for the 7-day pre-treatment skincare regimen period along with skincare regimen instructions. Clinical assessments will be performed including Investigator Clinical Efficacy Grading, Investigator Tolerability Grading, Subject Tolerability Grading, VISIA®-CR or Apple iPad Imaging, Antera® Imaging, and Self-Assessment Questionnaires.
At Visit 2 (Baseline, Day 0) if subjects continue to meet eligibility, then subjects will receive their 1st Brightening Treatment (3 layers). At Visits 3, 4, and 5 (weeks 2, 4 and 6), subjects will return to the clinical site to receive 2nd, 3rd, and 4th Brightening Treatment (4, 5, and 5 layers, respectively). Various assessments will be performed before and after the procedure and will include Investigator Clinical Efficacy Grading, Investigator Tolerability Grading, Subject Tolerability Grading, Subject Sensitivity Grading, Investigator Skin Frosting Evaluation, VISIA®-CR Imaging, Antera® Imaging, and Self-Assessment Questionnaires. At Visit 2, subjects will be provided with a Post Procedure Cream to use on Days 0, 1, and 2 post treatment. Subjects will continue to use Gentle Foaming Cleanser, Vitamin C Serum (starting on day 3), and Broad-Spectrum Sunscreen SPF 50 as the post-treatment skincare regimen. Subjects will be provided with skincare regimen instructions to be followed throughout the 12-week clinical study. To confirm compliance with usage, each container will be weighed on a scale at every visit and subjects will record topical usage in a daily diary.
At Visit 6 (week 12), subjects will return to the clinical site for follow-up clinical evaluations. The same assessments completed at previous visits will be repeated.
Exclusion Criteria:
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.
Other: Brightening Treatment
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).
Measurement of Investigator Clinical Grading
The primary efficacy endpoint will be favorable analysis of the Investigator Clinical Grading of the appearance of global pigmentation due to sun exposure, blemishes, and/or procedures according to the Post-Inflammatory Hyperpigmentation Area and Severity Index (PIHASI) at weeks 2,4, 6, and 12 versus baseline. The PIHASI measures three pigment charactersitics: Darkness (Score 0 absent, 1 slight, 3 moderate, 4 maximum), Heterogeneity (Score 0 absent, 1 slight, 3 moderate, 4 maximum), and Area (score 0: 0%, 1: 1-9%, 2: 10 - 29%, 3: 30 - 49%), 4: 50 - 69%m 5: 70 - 89%, 6: 90 - 100%). A decrease in score / value indicates an improvement.
Time frame: Baseline, weeks 2, 4, 6, and 12
Measurement of subject self assessment questionnaire
Subjects will complete a self-assessment questionnaire which will consist of a series of questions related to subjects' evaluation of product efficacy and attributes. Subjects are asked to rate based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement / question being asked.
Time frame: Visit 1, 2, 3, and 6
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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