Grupo Medcin
Osasco, São Paulo, 06023-070, Brazil
Location status: Recruiting
NCT Number: NCT07820943
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.
Interested in participating?
Request Info35 year–65 year
All sexes
Interventional
Not applicable
Osasco, São Paulo, 06023-070, Brazil
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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."
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.
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.
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."
Contact information is provided by the study sponsor or research team.
Brainfarma Industria Química e Farmacêutica S/A
Industry
Clinical, Subjective, and Instrumental Evaluation of Dermatological Acceptability and Efficacy in Improving Dryness, Hydration, and Skin Barrier Function in Participants With Xerosis
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.
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