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

NCT ID: NCT00843466

Last Updated: 2018-09-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-11-30

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.

Conditions

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Hand Dermatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mild, moisturizing hand cleanser

Intervention Type OTHER

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

Current Hand Cleanser

The control group will continue to use their current cleanser for all hand washing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan Fleischer, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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31963

Identifier Type: -

Identifier Source: secondary_id

IRB00002004

Identifier Type: -

Identifier Source: org_study_id

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