Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Dermatology/Plastic Surgery
Disease Category: Eczema (Atopic Dermatitis)

Trial Information

Research Study for Severe Chronic Hand Eczema

We are seeking volunteers 18 to 75 years old and in general good health who have been diagnosed with severe chronic hand eczema for at least the last 6 months. This condition must be resistant to standard therapy with topical corticosteroids.

Study Summary: The purpose of this study is to assess the safety and efficacy of an oral retinoid in the treatment of severe chronic hand eczema.

Study Information:

• Male or female adults 18 to 75 years old
• Study duration: Study participation includes a run-in period of up to 16 weeks, followed by a treatment period of up to 24 weeks and a follow-up period of 44 weeks.
• Study treatment: Once daily administration of one 30 mg soft capsule of investigational study drug or one soft capsule of placebo (inactive substance). Chance of receiving placebo is 50%. Study treatment will be randomly assigned to study participants in a double-blind manner (neither study site research staff nor participants will know which treatment is being assigned).
• Study procedures: There will be physical exams, hearing exams, labwork and X-rays.
• There is no charge for participation (study procedures, study medication, and study visits are no-cost).
• Reimbursement for time and/or travel cost: Compensation will be provided to qualified study participants. Note: There is no compensation for a pre-study visit.
• Principal Investigator: Theresa Scholz, M.D. of Accent Dermatology and Laser Institute, P.L.L.C.

Patient Inclusion Criteria:
PARTIAL LIST...

• History of severe chronic hand eczema for at least 6 months is required.
• Study participant must be resistant to therapy with topical corticosteroids, with a history of unsatisfactory outcome ** after at least 8 weeks of treatment within the past 6 months. ** Unsatisfactory outcome = no response, transient response to ongoing therapy, or lack of tolerability
• Females who are sexually active and able to become pregnant (this includes women who are not postmenopausal and/or who have not undergone surgical sterilization) must use a combination of two medically acceptable forms of birth control during the study.

Patient Exclusion Criteria:
PARTIAL LIST...

• Females who are pregnant or breast feeding may not participate.
• Those with chronic hand eczema that is normally controlled by standard non-medicated therapy (such as skin moisturization and protection, avoidance of irritants and allergens) and standard topical corticosteroid therapy may not participate.
• Anyone who is hypersensitive to retinoids or other Vitamin A derivatives, or to soybean oil, which may be a study medication component, is excluded from participation.
• Anyone who is being treated with systemic corticosteroids, retinoids, or immunosuppressants is excluded from participation if they will not be able to discontinue these treatments during the study.
• Participation in another study for an investigational drug within the 2 months before start of study treatment in this trial is an exclusion.

Mary Reid, Cheri Casey, Jodi Frazier, Dara Stillman or Jennifer Heit, Clinical Research Study Staff
Western States Clinical Research, Inc.
9201 W. 44th Avenue
Wheat Ridge, CO 80033
Phone: 303-940-0909
Fax: 303-940-0308
EMail: research@wscrinc.com

View Google Map

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.