Novel Topical Treatment of Hand Dermatitis (Eczema)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Biomedical Development Corporation
ClinicalTrials.gov Identifier:
NCT00614289
First received: January 31, 2008
Last updated: March 4, 2010
Last verified: October 2008
  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

Resource links provided by NLM:


Further study details as provided by Biomedical Development Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    Device: Epikeia Coatings
    Topical skin coating
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614289

Locations
United States, Texas
UTHSC Houston, Dermatology Clincial Research Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biomedical Development Corporation
Investigators
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 August 25, 2014