Novel Topical Treatment of Hand Dermatitis (Eczema)

Completed · Phase 1

Conditions studied: Contact Dermatitis, Eczema, Contact

In brief

This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis.

Key facts

Study ID

NCT00614289

Run by

Biomedical Development Corporation

People needed

30

Starts

2006-08-01

Expected to finish

2009-07-01

Last updated by the study team

2010-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UTHSC Houston, Dermatology Clincial Research Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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