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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hand Dermatosis

Intervention / Treatment
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* Other: Mild, moisturizing hand cleanser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mild moisturizing Hand Cleanser<br>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<br>* 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<br>|
| No Intervention: Current Hand Cleanser<br>The control group will continue to use their current cleanser for all hand washing. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment | Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe | Wk 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand dermatitis