Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis

Not Applicable

Completed

• Conditions: Hand Dermatosis
• Interventions: Other: Mild, moisturizing hand cleanser

• Registration Number: NCT00843466
• Lead Sponsor: Wake Forest University

Brief Summary

The purpose of this study is to find out if the use of a hand cleanser that adds moisture to the skin will help improve skin rashes caused by frequent hand washing (hand dermatitis).

Detailed Description

The objective of this protocol is to evaluate compatibility and potential benefits of daily use of a marketed mild, moisturizing hand cleanser for subjects/patients who experience mild to moderate hand dermatitis induced by frequent cleansing.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-04
• Study First Submitted: 2008-06-02
• Study Completion: 2008-11
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Results First Submitted: 2010-11-12
• Results First Submitted QC: 2017-01-26
• Results First Posted: 2017-03-16
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Between 18 and 65 years of age
• In general good health
• Hands free of cuts and abrasions
• Agree to adhere to the requirements listed in the informed consent
• Willing and able to use a mild, moisturizing, non-antibacterial cleanser for all hand washing purposes for the duration of the test period
• Willing to refrain from participating in any other clinical research trial for the duration of the study

Exclusion Criteria

• Documented allergies to study product components, soaps, latex, or fragrances
• History of the following conditions which may affect the response of the skin or the interpretation of the results: insulin dependent diabetes, or peripheral vascular diseases
• Participating in a concurrent clinical study involving treatment of your hands
• Currently using a prescription medication for hand dermatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild moisturizing Hand Cleanser	Mild, moisturizing hand cleanser	The test group will be provided with a mild moisturizing hand cleanser for all hand cleansing needs during the duration of the study.

Primary Outcome Measures

Name	Time	Method
Investigator Global Assessment	Wk 4	Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe

Trial Locations

Locations (1)

Wake Forest University Health Sciences Dermatology; 🇺🇸 Winston-Salem, North Carolina, United States