Completed
NCT Number: NCT01724229
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Villa Maria Care Center, Tucson, Arizona, United States
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
- 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.
Treatment and study plan
Primary outcomes
-
skin condition following treatment
Time frame: 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
Sponsors and collaborators
Lead sponsor
GM Associates
Industry
Registry information
Official study title
An Open-Label Clinical Case Series to Demonstrate Efficacy of the Kendall Skin Wellness System
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Nov 9, 2012
- Registry last updated
- Jun 25, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.