Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00843466
First received: June 2, 2008
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

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).


Condition Intervention
Hand Dermatosis
Other: mild, moisturizing hand cleanser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Efficacy of mild, moisturizing hand cleaner for improvement of hand dermatitis from frequent hand washing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2007
Study Completion Date: November 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The test group will be provided with a test product for all hand cleansing needs during the duration of the study.
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

No Intervention: 2
The control group will continue to use their current cleanser for hand washing.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843466

Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Alan Fleischer, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Alan Fleischer, Jr, MD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00843466     History of Changes
Other Study ID Numbers: 00002004, 31963
Study First Received: June 2, 2008
Last Updated: February 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Hand dermatitis

Additional relevant MeSH terms:
Dermatitis
Hand Dermatoses
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014