Phase 1 Study to Demonstrate Efficacy of Epikeia Coatings in a Human Clinical Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- 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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Ordinal scales measuring subjective efficacy, pain and itching.(85 Days)