Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07820943

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grupo Medcin

Osasco, São Paulo, 06023-070, Brazil

Location status: Recruiting

Location contact

Camila Canale

CONTACT

[email protected]

+55 (11) 98343 6952

Sergio Schalka

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Dermatological Acceptability Assessed by Clinical Dermatological Evaluation

    Time frame: Baseline and Day 28

    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.

Secondary outcomes

  1. Skin Hydration Assessed by Corneometer®

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

    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.

  2. Skin Barrier Recovery Assessed by Tewameter® Following Tape Stripping

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

    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.

  3. Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire Following Tape Stripping

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

    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."

  4. Skin Barrier Strengthening Assessed by Tewameter®

    Time frame: Day 7 and Day 28

    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.

  5. Skin Hydration Assessed by Corneometer®

    Time frame: Day 7 and Day 28

    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.

  6. Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire

    Time frame: Day 7 and Day 28

    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."

Study contacts

Contact information is provided by the study sponsor or research team.

Layane Melody Da Silva Reis Cavalcante

CONTACT

[email protected]

+55 (11) 4507-2183

Sponsors and collaborators

Lead sponsor

Brainfarma Industria Química e Farmacêutica S/A

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.