Clinical Case Series Evaluating Skin Wellness System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01724229
Recruitment Status : Completed
First Posted : November 9, 2012
Last Update Posted : June 25, 2013
Information provided by (Responsible Party):
GM Associates

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Moisture-associated Dermatitis Fungal Infection in Perineal Area Drug: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Clinical Case Series to Demonstrate Efficacy of the Kendall Skin Wellness System
Study Start Date : November 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01724229

United States, Arizona
Villa Maria Care Center
Tucson, Arizona, United States
United States, Pennsylvania
Deer Meadows Retirement Community
Southampton, Pennsylvania, United States
Sponsors and Collaborators
GM Associates
Study Director: Glenda J Motta, BSN, MPH, ET GM Associates Inc.

Kennedy K, Leighton B, Lutz J. Cost-effectiveness evaluation of a new alchool-free, film-forming incontinence skin protectant. proceedings from the European Conference on Advances in Wound Management, Amsterdam, Oct. 1996

Responsible Party: GM Associates Identifier: NCT01724229     History of Changes
Other Study ID Numbers: COV2012
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Keywords provided by GM Associates:
Incontinence-associated dermatitis
Skin care regimen for moisture-associated conditions
Perineal skin care
Fungal infection in perineal area

Additional relevant MeSH terms:
Skin Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors