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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Skin; Xerosis
• Intervention / Treatment: Other: moisturizing cream

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beatriz Santos Arnoni; Phone Number: +55 (11) 94742 3610; Email: beatriz.arnoni@medcin.com.br

Study Locations

• Brazil
  • São Paulo
    • Osasco, São Paulo, Brazil, 06023-070
      • Recruiting
      • Grupo Medcin
      • Contact: Camila Canale; Phone Number: +55 (11) 98343 6952; Email: camila.canale.ext@medcin.com.br
      • Principal Investigator: Sergio Schalka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Investigational Product Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Hydration Assessed by Corneometer®	Evaluation of skin hydration following a single application of the investigational product using Corneometer®. Skin hydration will be measured in arbitrary units (AU), with higher values indicating greater skin hydration.	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	Evaluation of skin barrier recovery following barrier disruption induced by tape stripping and a single application of the investigational product. Skin barrier function will be assessed using Tewameter® measurements of transepidermal water loss (TEWL). Lower TEWL values indicate improved skin barrier recovery and function.	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	Evaluation of the performance and attributes of the investigational product using a perceived efficacy questionnaire following skin barrier disruption induced by tape stripping and a single application of the product. Participants will report the intensity of symptoms and sensations, such as burning sensation, using response categories ranging from "Absent" to "Very Intense."	Immediately after application, 1 hour, and 2 hours after a single application.
Skin Barrier Strengthening Assessed by Tewameter®	Evaluation of skin barrier strengthening following continuous use of the investigational product. Skin barrier function will be assessed using Tewameter® measurements of transepidermal water loss (TEWL) after 7 and 28 days of product use. Lower TEWL values indicate improved skin barrier function and strengthening of the skin barrier.	Day 7 and Day 28
Skin Hydration Assessed by Corneometer®	Evaluation of the efficacy of the investigational product in improving skin hydration following continuous use. Skin hydration will be measured using Corneometer® and reported in arbitrary units (AU). Higher values indicate greater skin hydration and a better outcome.	Day 7 and Day 28
Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire	Evaluation of the performance and attributes of the investigational product using a perceived efficacy questionnaire after 7 and 28 days of product use. Responses will be recorded using a 5-category agreement scale ranging from "Strongly Disagree" to "Strongly Agree."	Day 7 and Day 28

Collaborators and Investigators

• Sponsor: Brainfarma Industria Química e Farmacêutica S/A
• Investigators: Principal Investigator: Sergio Schalka, Grupo Medcin

Study record dates

Study Major Dates

• Study Start (Estimated): September 14, 2026
• Primary Completion (Estimated): November 17, 2026
• Study Completion (Estimated): November 17, 2026

Study Registration Dates

• First Submitted: September 10, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 26-0197-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan has been established to share individual participant data (IPD) collected during this study. Participant confidentiality and privacy will be protected in accordance with applicable regulations and institutional policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No