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

NCT ID: NCT01826630

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Eczema Hand Eczema Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CLn BodyWash

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

Group Type ACTIVE_COMPARATOR

CLn BodyWash

Intervention Type OTHER

Comparing two washes to determine change in bacterial load.

Cetaphil Daily Facial Cleanser

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

Group Type ACTIVE_COMPARATOR

Cetaphil Daily Facial Cleanser

Intervention Type OTHER

Comparing two washes to determine change in bacterial load.

Interventions

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CLn BodyWash

Comparing two washes to determine change in bacterial load.

Intervention Type OTHER

Cetaphil Daily Facial Cleanser

Comparing two washes to determine change in bacterial load.

Intervention Type OTHER

Other Intervention Names

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Cetaphil Daily Facial

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TopMD Skin Care, Inc.

INDUSTRY

Sponsor Role collaborator

Shari L Hand

INDUSTRY

Sponsor Role lead

Responsible Party

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Shari L Hand

Clinical Research Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ohio State University

Gahanna, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CLN 2012H0327

Identifier Type: -

Identifier Source: org_study_id

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