NCT07820943招募中不适用
Clinical, Subjective, and Instrumental Evaluation of Dermatological Acceptability and Efficacy in Improving Dryness, Hydration, and Skin Barrier Function in Participants With Xerosis
Brainfarma Industria Química e Farmacêutica S/A1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2026年9月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Dermatological Acceptability Assessed by Clinical Dermatological Evaluation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: moisturizing cream (Other)
结局指标
主要结局
Dermatological Acceptability Assessed by Clinical Dermatological Evaluation
时间窗: 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.
次要结局
- 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)
- Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire(Day 7 and Day 28)
研究者
研究点 (1)
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