About this trial
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.
Eligibility criteria
Qualifiers
Female participants aged 18 to 55 years
Clinical diagnosis of facial post-inflammatory hyperpigmentation (PIH)
Self-identified as Black (including "preta" or "parda")
Fitzpatrick skin types IV to VI
Disqualifiers
Pregnant or breastfeeding women, or those planning pregnancy during the study period
Type 1 diabetes mellitus or related complications (e.g., nephropathy, dermatological conditions associated with diabetes, history of hypoglycemia, diabetic ketoacidosis, or hyperosmolar coma)
Known or suspected intolerance to similar cosmetic products
History of atopy or allergic reactions to cosmetic products
Trial design
Treatments tested in this trial
- Niacinamide and Bioceramide-Based Skincare Regimen
Treatment groups
Sponsors and collaborators
Hospital Israelita Albert Einstein
Lead sponsor
COTY BRASIL COMERCIO S.A.
Collaborator