Clinical Case Series Evaluating Skin Wellness System

An Open-Label Clinical Case Series to Demonstrate Efficacy of the Kendall 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.

Study Overview

• Status: Completed
• Conditions: Moisture-associated Dermatitis; Fungal Infection in Perineal Area
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States
      • Villa Maria Care Center
  • Pennsylvania
    • Southampton, Pennsylvania, United States
      • Deer Meadows Retirement Community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin condition following treatment	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	14 days

Collaborators and Investigators

• Sponsor: GM Associates
• Investigators: Study Director: Glenda J Motta, BSN, MPH, ET, GM Associates Inc.

Publications and helpful links

General Publications

• Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):61-74. doi: 10.1097/WON.0b013e31823fe246.
• 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

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 7, 2012
• First Posted (Estimate): November 9, 2012

Study Record Updates

• Last Update Posted (Estimate): June 25, 2013
• Last Update Submitted That Met QC Criteria: June 24, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Incontinence-associated dermatitis; Skin care regimen for moisture-associated conditions; Perineal skin care; Fungal infection in perineal area
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Dermatitis; Mycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Antifungal Agents; Clotrimazole; Miconazole
• Other Study ID Numbers: COV2012