Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
Sponsor: Brainfarma Industria Química e Farmacêutica S/A • ClinicalTrials.gov ID: NCT07820943
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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.
Interventions
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moisturizing cream
(Other)
A topical moisturizing product intended for the management of xerosis. The product will be applied twice daily to the lower limbs for 28 consecutive days. Its dermatological acceptability, effects on skin hydration, and effects on skin barrier recovery and strengthening will be evaluated through clinical, subjective, and instrumental assessments, including Corneometer® and Tewameter® measurements.
Eligibility criteria
Conditions
Locations
- Grupo Medcin — Osasco, São Paulo, Brazil
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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