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

March 24, 2026 updated by: Revision Skincare

A Clinical Study to Evaluate the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen on Healthy Female Subjects.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Skin Wellness Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Individuals in good general health (physical, mental, social well-being; not merely the absence of disease), based on medical history reported by the subject.
  2. Individuals of Female biological sex.
  3. Individuals between 20 to 65 years of age.
  4. Individuals with Fitzpatrick skin types I - VI
  5. Individuals of any race or ethnicity.
  6. Individuals with moderate global facial Hyperpigmentation (score of 3 for darkness, and heterogeneity, and a score of 3 to 4 for area on the PIHASI scale).
  7. Individuals with self-perceived facial pigmentation.

Exclusion Criteria:

  1. Individuals currently participating in or has participated in any other clinical study involving the face at another research facility or doctor's office within the past one (1) month.
  2. Individuals with no self-perceived facial pigmentation.
  3. Individuals diagnosed with known allergies to facial skin care products, moisturizers, or sunscreens.
  4. Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study according to subject self-report.
  5. Individuals who currently smoke or have smoked (cigarette, e-cigarettes, etc.) within the past 5 years.
  6. Individuals currently having or have a history of facial skin cancer within the past 5 years. Have or had cancer pertaining to any parts of the body and systems which in the opinion of the Investigator could interfere with the outcome of the study.
  7. Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Investigator Clinical Grading
Time Frame: Baseline, weeks 2, 4, 6, and 12
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. A decrease in score / value indicates an improvement.
Baseline, weeks 2, 4, 6, and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of subject self assessment questionnaire
Time Frame: Visit 1, 2, 3, and 6
Subjects will complete a self-assessment questionnaire which will consist of a series of questions related to subjects' evaluation of product efficacy and attributes.
Visit 1, 2, 3, and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revision Skincare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2024

Primary Completion (Actual)

January 23, 2025

Study Completion (Actual)

January 23, 2025

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS-2024-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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