Novel Topical Treatment of Hand Dermatitis (Eczema)
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Purpose
This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Contact Dermatitis Eczema, Contact |
Device: Epikeia Coatings |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 1 Study to Demonstrate Efficacy of Epikeia Coatings in a Human Clinical Trial |
- 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. [ Time Frame: 85 Days ] [ Designated as safety issue: Yes ]
- Ordinal scales measuring subjective efficacy, pain and itching. [ Time Frame: 85 Days ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | August 2006 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
-
Device: Epikeia Coatings
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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.
Contacts and Locations| United States, Texas | |
| UTHSC Houston, Dermatology Clincial Research Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Adelaide A. Hebert, MD | University of Texas Health Science Center, Department of Dermatoloy |
More Information
No publications provided
| Responsible Party: | Adelaide A. Hebert, MD, University of Texas Health Science Center-Houston, Dermatology Clincial Research Center |
| ClinicalTrials.gov Identifier: | NCT00614289 History of Changes |
| Other Study ID Numbers: | HSC-MS-06-0347, NIH Grant 1R43AR525441-1A1 |
| Study First Received: | January 31, 2008 |
| Last Updated: | March 4, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biomedical Development Corporation:
|
Mild to Moderate Hand Dermatitis Hand Eczema |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Contact Eczema Skin Diseases Skin Diseases, Eczematous |
ClinicalTrials.gov processed this record on May 23, 2013