DRKS00031504已完成Unknown
Protection of intact skin by an incontinence pad (MoliCare® Premium Form 4 drops) from a defined pH challenge - PHAG-INCO-001
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 75
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Healthy skin in the test area
- •Uniform skin colour and no erythema or dark pigmentation in the test area
- •Written Informed Consent to participate in the study
- •Willingness to actively participate in the study and to come to the scheduled visits
- •The subjects must be able to communicate with the attending study nurse or the attending dermatologist and to understand and follow up the requirements of this clinic-dermatological application study.
排除标准
- •Severe or chronic skin inflammations
- •Taking of drugs that may interfere with skin reactions (glucocorticoids, antiallergics, topical immune modulators, etc.)
- •Application of active substance-containing products and care products 7-10 days before the start of the test
- •Severe allergies or any serious side effects of cosmetic preparations ever occurred
- •Sun baths or solarium visits during the study
- •Female subjects: Pregnancy or lactation
- •Drug addicts, alcoholics
- •AIDS, HIV-positive or infectious hepatitis
- •Conditions which exclude a participation or might influence the test reaction/evaluation
- •Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
- •Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
- •Severe internal or chronic diseases
- •One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
- •Intolerability against adhesive dressings (e.g. acrylate)
- •Active skin disease at the test area
- •Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- •Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
- •Any topical medication at the test area within the last 3 days prior to the start of the study and/or throughout the entire course of the study
- •Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study
研究者
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