Novel Topical Treatment of Hand Dermatitis (Eczema)

NCT00614289 | Completed Phase 1

• 2 other identifiers: HSC-MS-06-0347NIH Grant 1R43AR525441-1A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contact Dermatitis; Eczema, Contact

Keywords

Mild to Moderate Hand Dermatitis; Hand Eczema

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Ordinal scales measuring subjective efficacy, pain and itching.

  85 Days

Interventions

Epikeia Coatings DEVICE

Topical skin coating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biomedical Development Corporation: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

UTHSC Houston, Dermatology Clincial Research Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Adelaide A. Hebert, MD

  University of Texas Health Science Center, Department of Dermatoloy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: August 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 8, 2010

Record last verified: 2008-10

Locations

US (1)