drugset / Trial / NCT07618572

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

NCT07618572

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-03-19
Primary completion
2026-10-31
Completion
2026-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bioceramides Unknown 0.2 % Topical
Subject Bioceramides Unknown 1 % Topical
Subject Bioceramides Unknown 3 % Topical
Subject Nicotinamide Other / unclassified 2 % Topical
Subject Nicotinamide Other / unclassified 5 % Topical