Fungal Infection in Perineal Area Clinical Trial
Official title:
An Open-Label Clinical Case Series to Demonstrate Efficacy of the Kendall Skin Wellness System
| Verified date | June 2013 |
| Source | GM Associates |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Deer Meadows Retirement Community | Southampton | Pennsylvania |
| United States | Villa Maria Care Center | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| GM Associates |
United States,
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. Review. — View Citation
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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |