An Open-Label Clinical Case Series to Demonstrate Efficacy of the Kendall Skin Wellness System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- skin condition following treatment
研究概览
简要总结
The purpose of this evaluation is to observe the performance of two (2) different skin care treatment protocols on the skin:
#1 Kendall™ Body Wash & Shampoo in combination with the Moisture Barrier Cream; or #2 Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream.
The scientific evidence supports using these types of skin care products to keep the skin healthy in the presence of moisture, urine, stool, or fungal infection. The cleansers are preferred over soap and water and can be applied on all areas of the skin. The Moisture Barrier Cream is formulated especially for skin exposed to moisture, urine, or stool. The Antifungal Cream is utilized for fungal infections associated with athlete's foot, jock itch, and ring worm to relieve itching, soreness, and irritation.
详细描述
The Kendall™ Body Wash & Shampoo is a no-rinse cleanser that gently removed dirt, urine, and stool while maintaining the natural pH of the skin (although it contains a shampoo component); it can be applied on all areas of the skin. Kendall™ Moisture Barrier Cream performs as a barrier to moisture and irritants when the natural barrier ability of the skin has been compromised.
Kendall™ 2-in-1 Cleanser is a no-rinse cleanser that gently removes dirt, urine, and stool and protects the skin from damage. Kendall™ Antifungal Cream is used on fungal infections to relieve itching and discomfort.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects with any of the following indications:
- •Erythema, maceration, or broken (denuded) skin from moisture, urinary or fecal incontinence
- •Irritated, unbroken skin (perineal area)
- •Fungal infection present in the perineal area
排除标准
- •An existing pressure ulcer of any stage where the product will be applied
- •Subjects not expected to survive the two week trial
- •Subjects under age 18
- •Subjects unable to provide informed consent (or whose designated power of attorney is unable to provide)
- •Subjects with known sensitivity to any product preservative or other ingredient.
研究组 & 干预措施
treatment with OTC drug products
- Body Wash & Shampoo applied directly to the skin or cloth; soiled area gently wiped clean. No rinsing necessary.
- Moisture Barrier Cream: Once area cleansed and dried thoroughly, a thin coat is gently applied to the area of the skin exposed to moisture twice daily for two weeks or as directed by doctor.
- 2-in-1 Cleanser: applied directly to the skin or a cloth and skin gently wiped clean. No rinsing necessary.
- Antifungal Cream: Once reddened area cleansed and dried thoroughly a thin layer is applied over the affected area twice daily for two weeks or as directed by doctor.
干预措施: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream (Drug)
结局指标
主要结局
skin condition following treatment
时间窗: 14 days
Results of skin assessment will be documented using the IAD (Incontinence-Associated Dermatitis) Skin Condition Assessment Tool. Individual subscores will be added together to provide a ten-point scale for measurement of skin condition
次要结局
未报告次要终点