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Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fields
  2. Minor Study First Submitted
The goal of this clinical trial is to evaluate the dermatological safety and efficacy of a moisturizing product in participants with moderate to severe xerosis of the lower limbs. The main questions it aims to answer are: * Does the investigational product demonstrate dermatological acceptability and absence of irritation under real-world conditions of use? * Does the investigational product improve skin hydration after single and repeated applications? * Does the investigational product improve skin barrier recovery and strengthen skin barrier function? * How do participants perceive the performance and efficacy of the investigational product? Participants will: * Apply the investigational moisturizing product twice daily for 28 days. * Undergo clinical dermatological evaluations to assess skin tolerability and potential irritation. * Undergo instrumental assessments of skin hydration using a Corneometer® and skin barrier function using a Tewameter®. * Complete questionnaires regarding product performance and perceived efficacy. The study will enroll 22 male and female participants aged 35 to 65 years with clinically confirmed moderate to severe xerosis of the lower limbs.
Trial Details
NCT Number NCT07820943
Lead Sponsor Brainfarma Industria Química e Farmacêutica S/A
Conditions
(from sponsor)
Xerosis, Dry Skin
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov