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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions: Niacinamide and Bioceramide-Based Skincare Regimen (Other) to Niacinamide and Bioceramide-Based Skincare Regimen (Drug)v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07618572
Lead Sponsor Hospital Israelita Albert Einstein
Collaborators: COTY BRASIL COMERCIO S.A.
Conditions
(from sponsor)		 Post-inflammatory Hyperpigmentation
Related terms Hyperpigmentation
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov