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Efficacy Evaluation of a Cosmetic Product for Facial Hyperpigmentation

Study acronym: HYPERPIG
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Lead sponsor: Brainfarma Industria Química e Farmacêutica S/A to Brainfarma Industria Química e Farmacêutica S/A
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 4 of 10 entries
  2. Secondary endpoints: details revised at 4 of 10 entriesv2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a single-center, single-blind clinical study designed to evaluate the efficacy of a depigmenting gel cream through clinical, subjective, and instrumental assessments. A total of 40 female participants, aged 30 to 60 years, will be enrolled and followed for 90 days while using the study product.Participants will be assigned to one of two groups. Group I will include 20 participants with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines, representing Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype. Group II will include 20 participants with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), representing Fitzpatrick skin phototypes II to V. The study aims to evaluate the product's effectiveness in reducing facial hyperpigmentation and improving skin appearance over the treatment period.
Trial Details
NCT Number NCT07769268
Lead Sponsor Brainfarma Industria Química e Farmacêutica S/A
Conditions
(from sponsor)		 Hyperpigmentation, Melasma (Facial Melasma)
Related terms Hyperpigmentation, Melanosis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov