Full Text View
Tabular View
No Study Results Posted
Related Studies
Novel Topical Treatment of Hand Dermatitis (Eczema)
This study is ongoing, but not recruiting participants.
Study NCT00614289   Information provided by Biomedical Development Corporation
First Received: January 31, 2008   Last Updated: June 10, 2009   History of Changes

January 31, 2008
June 10, 2009
August 2006
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00614289 on ClinicalTrials.gov Archive Site
Ordinal scales measuring subjective efficacy, pain and itching. [ Time Frame: 85 Days ] [ Designated as safety issue: Yes ]
Same as current
 
Novel Topical Treatment of Hand Dermatitis (Eczema)
Phase 1 Study to Demonstrate Efficacy of Epikeia Coatings in a Human Clinical Trial

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

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.

Phase I
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
  • Contact Dermatitis
  • Eczema, Contact
Device: Epikeia Coatings
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
30
November 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00614289
Adelaide A. Hebert, MD, University of Texas Health Science Center-Houston, Dermatology Clincial Research Center
HSC-MS-06-0347, NIH Grant 1R43AR525441-1A1
Biomedical Development Corporation
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Adelaide A. Hebert, MD University of Texas Health Science Center, Department of Dermatoloy
Biomedical Development Corporation
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP