Back to resultsCompatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis
Primary Purpose
Hand Dermatosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mild, moisturizing hand cleanser
Sponsored by
About this trial
This is an interventional treatment trial for Hand Dermatosis focused on measuring Hand dermatitis
Eligibility 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
Sites / Locations
- Wake Forest University Health Sciences Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Mild moisturizing Hand Cleanser
Current Hand Cleanser
Arm Description
The test group will be provided with a mild moisturizing hand cleanser for all hand cleansing needs during the duration of the study.
The control group will continue to use their current cleanser for all hand washing.
Outcomes
Primary Outcome Measures
Investigator Global Assessment
Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00843466
Brief Title
Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis
Official Title
Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Dermatosis
Keywords
Hand dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild moisturizing Hand Cleanser
Arm Type
Active Comparator
Arm Description
The test group will be provided with a mild moisturizing hand cleanser for all hand cleansing needs during the duration of the study.
Arm Title
Current Hand Cleanser
Arm Type
No Intervention
Arm Description
The control group will continue to use their current cleanser for all hand washing.
Intervention Type
Other
Intervention Name(s)
Mild, moisturizing hand cleanser
Intervention Description
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
Primary Outcome Measure Information:
Title
Investigator Global Assessment
Description
Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe
Time Frame
Wk 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Fleischer, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis
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