Status:
COMPLETED
Novel Topical Treatment of Hand Dermatitis (Eczema)
Lead Sponsor:
Biomedical Development Corporation
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Contact Dermatitis
Eczema, Contact
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 im...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00614289
Start Date
August 1 2006
End Date
July 1 2009
Last Update
March 8 2010
Active Locations (1)
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1
UTHSC Houston, Dermatology Clincial Research Center
Houston, Texas, United States, 77030