Back to resultsNovel Topical Treatment of Hand Dermatitis (Eczema)
Primary Purpose
Contact Dermatitis, Eczema, Contact
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Epikeia Coatings
Sponsored by
About this trial
This is an interventional treatment trial for Contact Dermatitis focused on measuring Mild to Moderate Hand Dermatitis, Hand Eczema
Eligibility Criteria
Inclusion Criteria:
Subjects must meet the following inclusion criteria:
- 18 years of age or older;
- have mild to moderate hand dermatitis, according to Investigator Global Assessment (see below);
- be generally healthy, as determined by brief medical history;
- have a negative urine test for pregnancy if female, and use of highly effective method of birth control, such as condoms & spermacide, implants, injectables, combined oral contraceptives, intrauterine device (IUD's), sexual abstinence, or a vasectomized partner. For subjects using a hormonal contraceptive method, [i.e., birth control pill (BCP)], the dose and type of BCP should stay constant 1 month prior to enrollment and throughout the study, and
- be capable of understanding and signing the consent form.
Exclusion Criteria:
Subjects will be excluded from the study if they:
- have clinically relevant allergic or irritant contact dermatitis and the inability to avoid exposure;
- have severe and very severe hand dermatitis according to the Investigator Global Assessment;
- have severe vesiculation or bullae;
- have a history of psoriasis, contact urticaria, and/or pustular diseases of the hands;
- have had therapy of the hands with potent topical corticosteroids within one month of enrollment;
- have used systemic treatment with oral retinoids, corticosteroids, or with PUVA within the 8 week period prior to the beginning of the study
- have a history of alcoholism or drug abuse;
- have a history or current evidence of a chronic or infectious skin disease; and
- are pregnant or lactating females, or using method of birth control that does not comply with highly effective methods of birth control listed under inclusion criteria; Pregnant or lactating females, or using method of birth control that does not comply with highly effective methods of birth control listed under inclusion criteria.
Sites / Locations
- UTHSC Houston, Dermatology Clincial Research Center
Outcomes
Primary Outcome Measures
The endpoints for evaluation will be the within subject (test vs. control hands) comparison on Investigator Global Assessment, and Hand Eczema Area and Severity Scores.
Secondary Outcome Measures
Ordinal scales measuring subjective efficacy, pain and itching.
Full Information
NCT ID
NCT00614289
First Posted
January 31, 2008
Last Updated
March 4, 2010
Sponsor
Biomedical Development Corporation
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00614289
Brief Title
Novel Topical Treatment of Hand Dermatitis (Eczema)
Official Title
Phase 1 Study to Demonstrate Efficacy of Epikeia Coatings in a Human Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biomedical Development Corporation
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis.
Detailed Description
Hand dermatitis was chosen for investigation due to high incidence and typical symmetrical involvement that allows for right/left treatment comparisons. Hand dermatitis is also important due to its implication on healthcare workers in particular, where frequent hand washing and chronic occlusion from gloving, provide a route for skin sensitization to natural rubber latex proteins increase the risk of colonization of microorganisms on the skin, and thereby increase the likelihood of contact dermatitis.
This feasibility study will be performed to evaluate the efficacy of PVDF coatings in treating chronic hand dermatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis, Eczema, Contact
Keywords
Mild to Moderate Hand Dermatitis, Hand Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Epikeia Coatings
Intervention Description
Topical skin coating
Primary Outcome Measure Information:
Title
The endpoints for evaluation will be the within subject (test vs. control hands) comparison on Investigator Global Assessment, and Hand Eczema Area and Severity Scores.
Time Frame
85 Days
Secondary Outcome Measure Information:
Title
Ordinal scales measuring subjective efficacy, pain and itching.
Time Frame
85 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must meet the following inclusion criteria:
18 years of age or older;
have mild to moderate hand dermatitis, according to Investigator Global Assessment (see below);
be generally healthy, as determined by brief medical history;
have a negative urine test for pregnancy if female, and use of highly effective method of birth control, such as condoms & spermacide, implants, injectables, combined oral contraceptives, intrauterine device (IUD's), sexual abstinence, or a vasectomized partner. For subjects using a hormonal contraceptive method, [i.e., birth control pill (BCP)], the dose and type of BCP should stay constant 1 month prior to enrollment and throughout the study, and
be capable of understanding and signing the consent form.
Exclusion Criteria:
Subjects will be excluded from the study if they:
have clinically relevant allergic or irritant contact dermatitis and the inability to avoid exposure;
have severe and very severe hand dermatitis according to the Investigator Global Assessment;
have severe vesiculation or bullae;
have a history of psoriasis, contact urticaria, and/or pustular diseases of the hands;
have had therapy of the hands with potent topical corticosteroids within one month of enrollment;
have used systemic treatment with oral retinoids, corticosteroids, or with PUVA within the 8 week period prior to the beginning of the study
have a history of alcoholism or drug abuse;
have a history or current evidence of a chronic or infectious skin disease; and
are pregnant or lactating females, or using method of birth control that does not comply with highly effective methods of birth control listed under inclusion criteria; Pregnant or lactating females, or using method of birth control that does not comply with highly effective methods of birth control listed under inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaide A. Hebert, MD
Organizational Affiliation
University of Texas Health Science Center, Department of Dermatoloy
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTHSC Houston, Dermatology Clincial Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Novel Topical Treatment of Hand Dermatitis (Eczema)
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