A Study to Assess CLn® BodyWash for Reducing Skin Fauna in Patients With Hand Eczema

Shari L Hand

Status: Terminated

Conditions: Atopic Dermatitis; Hand Eczema; Eczema

Treatments: Other: CLn BodyWash; Other: Cetaphil Daily Facial Cleanser

Study type: Interventional

Funder types: Industry

Identifiers

NCT01826630

CLN 2012H0327

Details and patient eligibility

About

The primary objective of this protocol is to acquire pilot data for a larger study to test the following hypothesis: Treatment of the hands of patients with chronic hand dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed as a cosmetic product containing a dilute concentration of less than 0.01% sodium hypochlorite and less than 0.005% concentration as it is lathered, will result in a statistically significant reduction in the number of skin fauna present on the hands of these patients compared to treatment of such patients with traditional wash used clinically such as Cetaphil Daily Facial Cleanser.

Full description

Patients with Hand Eczema will be asked to wash with either a CLn BodyWash or Cetaphil Daily Facial Cleanser. Patients and study staff will be blinded. Hand swabs will be done prior to the wash and after 20 minutes. The average time spent in the study for each patient should be less than 2 hours unless an Adverse Event occurs.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Seen by an OSU Dermatology provider at OSU Dermatology East after the date of approval of this protocol
• Ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals
• Willingness to participate in a research study.
• Diagnosis of chronic hand dermatitis

Exclusion criteria

• Inability to provide informed consent
• Allergy to any of the treatments used

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups

CLn BodyWash

Active Comparator group

Description:

CLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis

Treatment:

Other: CLn BodyWash

Cetaphil Daily Facial Cleanser

Active Comparator group

Description:

Cetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis

Treatment:

Other: Cetaphil Daily Facial Cleanser