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

NCT07820943 | Recruiting

• 1 other identifier: 26-0197-06
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Xerosis; Dry Skin

Outcome Measures

Primary Outcomes (1)

• Dermatological Acceptability Assessed by Clinical Dermatological Evaluation

  Dermatological acceptability of the investigational product under real-world conditions of use, including the assessment of signs of skin irritation and participant-reported discomfort sensations. Evaluations will be performed by a dermatologist throughout the study period.

  Baseline and Day 28

Secondary Outcomes (6)

• Skin Hydration Assessed by Corneometer®

  Immediately after application, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 12 hours, 24 hours, and 48 hours after a single application.

• Skin Barrier Recovery Assessed by Tewameter® Following Tape Stripping

  Immediately after application, 1 hour, 2 hours, and 4 hours after a single application.

• Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire Following Tape Stripping

  Immediately after application, 1 hour, and 2 hours after a single application.

• Skin Barrier Strengthening Assessed by Tewameter®

  Day 7 and Day 28

• Skin Hydration Assessed by Corneometer®

  Day 7 and Day 28

Study Arms (1)

Investigational Product Group

EXPERIMENTAL

Participants with moderate to severe xerosis of the lower limbs will apply the investigational moisturizing product twice daily for 28 days. Dermatological, subjective, and instrumental assessments will be performed to evaluate skin tolerability, hydration, and skin barrier function.

Other: moisturizing cream

Interventions

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.

Investigational Product Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

Study Sites (1)

Grupo Medcin

Osasco, São Paulo, 06023-070, Brazil

RECRUITING

Study Officials

• Sergio Schalka

  Grupo Medcin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Layane Melody Da Silva Reis Cavalcante

CONTACT

+55 (11) 4507-2183; layane.reis@brainfarma.ind.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): November 17, 2026
• Study Completion (Estimated): November 17, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)