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

A Double-Blind Pilot Study To Assess The Feasibility of a Larger Study to Assess The Efficacy of A Novel Gel Wash Cleanser Formulated With Sodium Hypochlorite To Reduce Skin Fauna In Patients With Chronic Hand Dermatitis/Atopic Dermatitis.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01826630
Enrollment
4
Registered
2013-04-08
Start date
2013-07-31
Completion date
2014-10-31
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Eczema, Hand Eczema

Keywords

CLn Body Wash, CLn BodyWash

Brief summary

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.

Detailed 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.

Interventions

OTHERCLn BodyWash

Comparing two washes to determine change in bacterial load.

Comparing two washes to determine change in bacterial load.

Sponsors

TopMD Skin Care, Inc.
CollaboratorINDUSTRY
Shari L Hand
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Amount of Skin Faunaone washMean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026