Clinical Case Series Evaluating Skin Wellness System

GM Associates

Status: Completed

Conditions: Fungal Infection in Perineal Area; Moisture-associated Dermatitis

Treatments: Drug: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01724229

COV2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

treatment with OTC drug products

Other group

Description:

* 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.

Treatment:

Drug: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream