DRKS00031151已完成Unknown
An exploratory randomized controlled trial to evaluate the effects of a leave-on product on the structural strength of the dermo epidermal junction and related molecular markers in elderly subjects with dry skin - CRC-SP-A-43
Charité – Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Clinical Research Center for Hair and Skin Science and the Institute of Clinical Nursing Science, Charité Center for Health and Human Sciences0 个研究点目标入组 12 人开始时间: 2023年1月30日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 65 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Aged healthy volunteers with dry skin in the skin area of interest (ODS categories 1 and/or 2)
- •Sex: Male or Female
- •65 to 85 years,
- •Phototype I to III according to the Fitzpatrick classification,
- •Body Mass Index between 20 and 30 kg/m2,
- •Non-smoker of at least one year,
- •Able to give written informed consent,
- •Willing and able to fulfill the study requirements.
排除标准
- •ODS 3 or 4 in the skin area of interest,
- •Unstable chronic condition (e.g. uncontrolled hypertension, heart disease),
- •Known or suspected defect of healing,
- •Tendency to keloid or hypertrophic scars,
- •Diabetes mellitus,
- •Hormone replacement therapy within last 3 months.
- •Any acute or chronic pathology that may interfere with the trial conduct, from investigator point of view,
- •Acute or chronic wounds in the skin area of interest,
- •Any skin affection which may interfere with the trial assessment, like atopic dermatitis, urticaria, psoriasis or scar on investigational areas,
- •Tattoos in the skin area of interest,
- •Any current skin malignancy,
- •Any known allergies to one of the compounds of the investigational product,
- •Any regular treatment which may affect the blood coagulation and hemostasis (anticoagulant medications, NSAID, etc.) before the suction blister induction (Visit 4), (one NSAID within four days is allowed),
- •Any physical treatment (like laser or surgery) on the arms within the last 6 months,
- •Use of topical or systemic treatment on the investigational areas within the past 4 weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, vitamin C, etc.) that would interfere with assessment and/or investigational treatments,
- •Allergy to band-aid,
- •UV sessions or strong sun exposure of the arms during the study period,
- •Current participation or participation within the last 4 weeks in another clinical trial,
- •In the opinion of the investigator unlikely to comply with the clinical trial protocol.
研究者
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