Non-controlled, Exploratory, Single-arm Clinical Study With a Water-in-oil Emulsion to Test the Protecting and Caring Effect of the Formulation on 'Incontinence-care Product Requiring' Fecal and/or Urinary Incontinent Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Assessment of skin tolerability (single parameters) by the physician regarding erythema, oedema, dryness, papules or pustules
研究概览
简要总结
The aim of this study is to test the protecting and caring effect of a protective balm on patients suffering from urinary and/or fecal incontinence and need incontinence care products.
详细描述
Patients receive at least two applications of the test product in the application area daily for two weeks. An additional washing product is used during the entire application time. The caring and skin protecting effects, the skin tolerability and cosmetic efficacy of the test product will be assessed by a physician, a nurse and the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Blinding of sponsor label (blanco primary packaging)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is capable of understanding the information given to them and providing informed consent
- •70 years of age and older
- •Patients with incontinence (fecal and/or urinary), requiring incontinence protection material
- •Skin type on Fitzpatrick scale: Between I to IV
排除标准
- •Current cancer treatment such as chemotherapy, irradiation
- •Documented allergies to skin care and / or skin cleansing products
- •Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- •Incontinence-associated dermatitis (IAD) stage >1a
- •Active skin disease at the test area
- •Any topical medication at the test area within the last 3 days prior to the start of the study and / or hroughout te entire course of the study
- •Mini-Mental-Status-Test (MMST) < 20
研究组 & 干预措施
Test Product (P-001230/2)
Patients receive at least two applications of the test product P-001230/2 in the application area every day. An additional washing product is used to clean the skin.
干预措施: Protective Balm (Other)
结局指标
主要结局
Assessment of skin tolerability (single parameters) by the physician regarding erythema, oedema, dryness, papules or pustules
时间窗: Day 1 vs Day 15±2 (after 2 weeks of test product application)
Single parameters (erythema, oedema, dryness, papules or pustules) will be assessed by a scale.
Assessment of product characteristics
时间窗: Day 15 ±2 (after 2 weeks of test product application)
Product characteristics will be assessed by the patient in a questionnaire regarding sensation during application of the product by the nurse (feeling during application on the skin).
Global assessment of tolerability by the phyisician
时间窗: Day 15 ±2 (after 2 weeks of test product application)
The physician will evaluate the global skin tolerability, according to a scale (taking results of skin tolerability (single parameters), and his or her personal assessment of tolerability at all time points into account).
Global assessment of cosmetic efficacy by the physician
时间窗: Day 15 ±2 (after 2 weeks of test product application)
The physician will evaluate the global efficacy, according to a scale.
Assessment of skin condition by a nurse
时间窗: Day 1 and Day 15 ±2 (after 2 weeks of test product application)
The skin condition (color, turgor and surface of the skin) will be assessed by binary queries (yes/no). The caring and protecting status of the skin will be assessed by an Visual Analogue Scale (VAS).
Assessment of product characteristics by a nurse
时间窗: Day 15 ±2 (after 2 weeks of test product application)
Product characteristics regarding scent, spreadability, removability, appearance of the skin (redness, dryness) will be assessed by a questionnaire with predefined answer options.
Global assessment of the product by a nurse
时间窗: Day 15 ±2 (after 2 weeks of test product application)
The nurse will evaluate the global assessment of the product, according to a scale (taking results of the skin condition regarding the caring and protecting status and the product characteristics into account).
Assessment of skin tolerability by the patient
时间窗: Day 15 ±2 (after 2 weeks of test product application)
The overall subjective skin status after application of the test product will be evaluated summarized for the whole application period according to a scale (each parameter (itching, burning, stinging, pain, soreness) separately).
次要结局
未报告次要终点