Clinical trial NCT00614289: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contact Dermatitis
Eczema, Contact
Keywords: Mild to Moderate Hand Dermatitis
Hand Eczema
Lead sponsor: Biomedical Development Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2008-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Subjects must meet the following inclusion criteria:

1. 18 years of age or older;
2. have mild to moderate hand dermatitis, according to Investigator Global Assessment (see below);
3. be generally healthy, as determined by brief medical history;
4. 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
5. be capable of understanding and signing the consent form.

Exclusion Criteria:

Subjects will be excluded from the study if they:

1. have clinically relevant allergic or irritant contact dermatitis and the inability to avoid exposure;
2. have severe and very severe hand dermatitis according to the Investigator Global Assessment;
3. have severe vesiculation or bullae;
4. have a history of psoriasis, contact urticaria, and/or pustular diseases of the hands;
5. have had therapy of the hands with potent topical corticosteroids within one month of enrollment;
6. have used systemic treatment with oral retinoids, corticosteroids, or with PUVA within the 8 week period prior to the beginning of the study
7. have a history of alcoholism or drug abuse;
8. have a history or current evidence of a chronic or infectious skin disease; and
9. 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.

Primary outcomes:
measure: 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.
timeFrame: 85 Days
Secondary outcomes:
measure: Ordinal scales measuring subjective efficacy, pain and itching.
timeFrame: 85 Days
Other outcomes:
Locations:
city: Houston
country: United States
facility: UTHSC Houston, Dermatology Clincial Research Center
state: Texas
Study officials:
affiliation: University of Texas Health Science Center, Department of Dermatoloy
name: Adelaide A. Hebert, MD
role: PRINCIPAL_INVESTIGATOR
References: