Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis
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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 |
- 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 |
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| United States, North Carolina | |
| Wake Forest University Health Sciences Dermatology | |
| Winston Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Alan Fleischer, MD | Wake Forest University |
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 University:
|
Hand dermatitis |
Additional relevant MeSH terms:
|
Dermatitis Hand Dermatoses Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013