Clinical Case Series Evaluating Skin Wellness System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GM Associates
ClinicalTrials.gov Identifier:
NCT01724229
First received: November 7, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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 Intervention
Moisture-associated Dermatitis
Fungal Infection in Perineal Area
Drug: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by GM Associates:

Primary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724229

Locations
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
Investigators
Study Director: Glenda J Motta, BSN, MPH, ET GM Associates Inc.
  More Information

No publications provided

Responsible Party: GM Associates
ClinicalTrials.gov Identifier: NCT01724229     History of Changes
Other Study ID Numbers: COV2012
Study First Received: November 7, 2012
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

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:
Dermatitis
Mycoses
Skin Diseases
Antifungal Agents
Clotrimazole
Miconazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014