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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00614289
Other study ID # HSC-MS-06-0347
Secondary ID NIH Grant 1R43AR
Status Completed
Phase Phase 1
First received January 31, 2008
Last updated March 4, 2010
Start date August 2006
Est. completion date July 2009

Study information

Verified date October 2008
Source Biomedical Development Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Device:
Epikeia Coatings
Topical skin coating

Locations

Country Name City State
United States UTHSC Houston, Dermatology Clincial Research Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
Biomedical Development Corporation National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 85 Days Yes
Secondary Ordinal scales measuring subjective efficacy, pain and itching. 85 Days Yes
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