Clinical Case Series Evaluating Skin Wellness System

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GM Associates
• Treatments: Antifungal Agents; Clotrimazole; Miconazole

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.