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

NCT00843466 | Completed Results

• 2 other identifiers: IRB0000200431963
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Hand Dermatosis

Keywords

Hand dermatitis

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment

  Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe

  Wk 4

Study Arms (2)

Mild moisturizing Hand Cleanser

ACTIVE COMPARATOR

The test group will be provided with a mild moisturizing hand cleanser for all hand cleansing needs during the duration of the study.

Other: Mild, moisturizing hand cleanser

Current Hand Cleanser

NO INTERVENTION

The control group will continue to use their current cleanser for all hand washing.

Interventions

Mild, moisturizing hand cleanser OTHER

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

Mild moisturizing Hand Cleanser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hand Dermatoses

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Jamie Regan
• Organization: Unilever

Jamie.Regan@unilever.com

203-381-4448

Study Officials

• Alan Fleischer, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: February 13, 2009
• Study Start: May 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 10, 2018
• Results First Posted: March 16, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)