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

NCT07501000 | Completed

• 1 other identifier: RS-2024-05
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Roughness; Hyperpigmentation; Skin Ageing; Post Inflammatory Hyperpigmentation

Keywords

brightening; dark spots; hyperpigmentation; pigmentation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, weeks 2, 4, 6, and 12

Secondary Outcomes (1)

• Measurement of subject self assessment questionnaire

  Visit 1, 2, 3, and 6

Study Arms (1)

Skincare Regimen

EXPERIMENTAL

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

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).

Skincare Regimen

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: The study included biological female subjects as part of the inclusion criteria
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals in good general health (physical, mental, social well-being; not merely the absence of disease), based on medical history reported by the subject.
• Individuals of Female biological sex.
• Individuals between 20 to 65 years of age.
• Individuals with Fitzpatrick skin types I - VI
• Individuals of any race or ethnicity.
• 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).
• Individuals with self-perceived facial pigmentation.

You may not qualify if:

• 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.
• Individuals with no self-perceived facial pigmentation.
• Individuals diagnosed with known allergies to facial skin care products, moisturizers, or sunscreens.
• Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study according to subject self-report.
• Individuals who currently smoke or have smoked (cigarette, e-cigarettes, etc.) within the past 5 years.
• 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.
• Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.

Sponsors & Collaborators

• Revision Skincare: lead

Study Sites (1)

Skin Wellness Dermatology

Birmingham, Alabama, 35209, United States

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: October 7, 2024
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: June 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)