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RECRUITING

NCT07820943

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

Sponsor: Brainfarma Industria Química e Farmacêutica S/A

View on ClinicalTrials.gov

Summary

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.

Official title: Clinical, Subjective, and Instrumental Evaluation of Dermatological Acceptability and Efficacy in Improving Dryness, Hydration, and Skin Barrier Function in Participants With Xerosis

Key Details

Gender

All

Age Range

35 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-14

Completion Date

2026-11-17

Last Updated

2026-09-15

Healthy Volunteers

Yes

Conditions

Xerosis Dry Skin

Interventions

OTHER

moisturizing cream

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.

Inclusion Criteria: * Male and female participants aged 36 to 65 years. * Participants presenting moderate to severe xerosis of the lower limbs, corresponding to grades 2 or 3 on the Overall Dry Skin Score (ODS) scale, confirmed by clinical evaluation. * Participants presenting a stratum corneum hydration index between 35 and 55 arbitrary units (AU), as measured by corneometry on the forearm during the eligibility assessment. * Participants considered healthy by the investigator, with no medical conditions or use of medications that could pose an undue risk or interfere with the study results. * Willingness to comply with all study procedures and attend the study site on the scheduled dates and times for assessments. * Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF). Exclusion Criteria: * Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study, when applicable. * Use of anti-inflammatory, immunosuppressive, antihistamine, or any other medication that, in the investigator's opinion, may interfere with skin condition assessments or study outcomes. * Presence of skin marks in the test area that may interfere with clinical or instrumental evaluations of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn. * Presence of active atopic dermatitis, eczema, or other dermatoses that may interfere with evaluation of the test area. * Active localized or generalized skin diseases and/or lesions in the assessment area that, in the investigator's opinion, may compromise participation in the study. * Immunosuppression due to medication use or active disease. * Uncontrolled endocrine disorders. * Presence of significant vascular alterations in the lower limbs, such as severe venous insufficiency, significant edema, lymphedema, or ulcers that may interfere with study assessments. * Relevant medical history or current evidence of alcohol or substance abuse. * Known history of or suspected intolerance to products of the same category. * Intense sun exposure within 15 days prior to the baseline assessment. * Aesthetic or dermatological treatments within 4 weeks prior to the baseline assessment. * Procedures that may temporarily alter skin condition in the test area, such as exfoliation or hair removal, within the timeframe specified by the study protocol. * Any other condition that, in the investigator's opinion, may pose a risk to the participant, interfere with protocol compliance, or compromise the interpretation of study results.

Locations (1)

Grupo Medcin

Osasco, São Paulo, Brazil