Novel Topical Treatment of Hand Dermatitis (Eczema)

NCT ID: NCT00614289

Last Updated: 2010-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-07-31

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.

Conditions

Contact Dermatitis; Eczema, Contact

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

Epikeia Coatings

Topical skin coating

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Biomedical Development Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

University of Texas Health Science Center-Houston, Dermatology Clincial Research Center

Principal Investigators

Adelaide A. Hebert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center, Department of Dermatoloy

Locations

UTHSC Houston, Dermatology Clincial Research Center

Houston, Texas, United States

Countries

United States

Other Identifiers

NIH Grant 1R43AR525441-1A1

Identifier Type: -

Identifier Source: secondary_id

HSC-MS-06-0347

Identifier Type: -

Identifier Source: org_study_id