Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
2026年9月15日 更新者:Brainfarma Industria Química e Farmacêutica S/A
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.
研究概览
研究类型
介入性
注册 (估计的)
22
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Layane Melody Da Silva Reis Cavalcante
- 电话号码:+55 (11) 4507-2183
- 邮箱:layane.reis@brainfarma.ind.br
学习地点
-
-
São Paulo
-
Osasco、São Paulo、巴西、06023-070
- 招聘中
- Grupo Medcin
-
接触:
- Camila Canale
- 电话号码:+55 (11) 98343 6952
- 邮箱:camila.canale.ext@medcin.com.br
-
首席研究员:
- Sergio Schalka
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dermatological Acceptability Assessed by Clinical Dermatological Evaluation
大体时间: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.
|
Baseline and Day 28
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Skin Hydration Assessed by Corneometer®
大体时间: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.
|
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
大体时间: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.
|
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
大体时间: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."
|
Immediately after application, 1 hour, and 2 hours after a single application.
|
|
Skin Barrier Strengthening Assessed by Tewameter®
大体时间: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.
|
Day 7 and Day 28
|
|
Skin Hydration Assessed by Corneometer®
大体时间: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.
|
Day 7 and Day 28
|
|
Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire
大体时间: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."
|
Day 7 and Day 28
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Sergio Schalka、Grupo Medcin
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月14日
初级完成 (估计的)
2026年11月17日
研究完成 (估计的)
2026年11月17日
研究注册日期
首次提交
2026年9月10日
首先提交符合 QC 标准的
2026年9月10日
首次发布 (实际的)
2026年9月15日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月15日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 26-0197-06
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.