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

Hand Dermatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843466
• Other study ID #: IRB00002004
• Secondary ID: 31963
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: November 2008

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Hand Dermatoses
• Hand Dermatosis
• Skin Diseases

Intervention

Other:
• Mild, moisturizing hand cleanser
Hand cleanser ingredient list: Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Cocamide MEA, PEG-5 Cocamide Cocamidopropyl Betaine Sodium Lauroyl Sarcosinate Glycerin Petrolatum Soybean Oil Sodium Hydroxypropyl Starch Phosphate Lauric Acid Lauryl Alcohol PEG-14M Guar hydroxypropyl trimonium chloride DMDM Hydantoin; Iodopropynyl Butylcarbamate Etidronic Acid Tetrasodium EDTA Titanium Dioxide Fragrance Sodium Hydroxide Water

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Global Assessment	Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe	Wk 4