Clinical Case Series Evaluating Skin Wellness System
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.
Fungal Infection in Perineal Area
Drug: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Clinical Case Series to Demonstrate Efficacy of the Kendall Skin Wellness System|
- skin condition following treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]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
|Study Start Date:||November 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
treatment with OTC drug products
||Drug: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724229
|United States, Arizona|
|Villa Maria Care Center|
|Tucson, Arizona, United States|
|United States, Pennsylvania|
|Deer Meadows Retirement Community|
|Southampton, Pennsylvania, United States|
|Study Director:||Glenda J Motta, BSN, MPH, ET||GM Associates Inc.|