Fungal Infection in Perineal Area, Moisture-associated Dermatitis
Conditions
Keywords
Incontinence-associated dermatitis, Skin care regimen for moisture-associated conditions, Perineal skin care, Fungal infection in perineal area
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.
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.
Interventions
DRUGKendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream
Sponsors
GM Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| skin condition following treatment | 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 |
Countries
United States
Outcome results
None listed