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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00843466
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : March 16, 2017
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( 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).

Condition or disease Intervention/treatment Phase
Hand Dermatosis Other: Mild, moisturizing hand cleanser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis
Study Start Date : May 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : November 2008

Arm Intervention/treatment
Active Comparator: 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.
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: Current Hand Cleanser
The control group will continue to use their current cleanser for all hand washing.



Primary Outcome Measures :
  1. Investigator Global Assessment [ Time Frame: Wk 4 ]
    Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843466


Locations
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United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
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Principal Investigator: Alan Fleischer, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00843466    
Other Study ID Numbers: IRB00002004
31963
First Posted: February 13, 2009    Key Record Dates
Results First Posted: March 16, 2017
Last Update Posted: September 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Hand dermatitis
Additional relevant MeSH terms:
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Dermatitis
Skin Diseases
Hand Dermatoses