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

Completed · Not applicable

Conditions studied: Hyperpigmentation, Skin Ageing, Post Inflammatory Hyperpigmentation, Skin Roughness

In brief

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 facts

Study ID

NCT07501000

Run by

Revision Skincare

People needed

11

Starts

2024-10-07

Expected to finish

2025-01-23

Last updated by the study team

2026-06-05

Who can join

Age: 20 and older, up to 65. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• Skin Wellness Dermatology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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