Clinical Trial

Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women

Recruiting
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Summary
The goal of this clinical trial is to evaluate whether the use of dermocosmetics containing Bioceramides and Niacinamide can improve post-inflammatory hyperpigmentation and promote positive impacts on self-esteem and quality of life in Brazilian Black women with facial hyperpigmentation (Fitzpatrick skin types IV to VI). The main questions it aims to answer are: * Does the treatment improve hyperpigmentation severity as measured by HASI and IGA scores? * Does the treatment improve participants' self-esteem and quality of life as assessed by MELASQoL and DLQI questionnaires? Participants will: * Use a standardized skincare routine including cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen for 12 weeks. * Attend study visits at baseline, week 6, and week 12. * Undergo standardized facial photography and clinical assessments by specialists at baseline, week 6, and week 12. * Complete questionnaires related to self-esteem and quality of life at baseline, week 6, and week 12.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-25.
Trial Details
NCT Number NCT07618572
Lead Sponsor Hospital Israelita Albert Einstein
Collaborators: COTY BRASIL COMERCIO S.A.
Conditions Post-inflammatory Hyperpigmentation
Enrollment 60 participants
Start Date 2026-03-19
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-04