RESEARCH STUDY FOR SEVERE CHRONIC HAND ECZEMA

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, PLLC

INCLUSION CRITERIA (Partial List):

• History of severe chronic hand eczema for at least 6 months is required.

• Study participants must be resistent 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.

EXCLUSION CRITERIA (Partial List):

• Females who are pregnant or breastfeeding may not participate.

• Those with chronic hand eczema that is normally controlled by standard non-medicated therapy (such as skin moisurization and protection, avoidance of irritants and allergans) and standard topical corticosteroid therapy may not participate.

• 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.

Please contact our site for further information about this study!

CONTACT INFORMATION:

Mary Reid, Jodi Frazier, Jenny Heit, Cheri Casey or Dara Stillman

Western States Clinical Research, Inc.
9201 W. 44th Avenue
Wheat Ridge, CO 80033

303-940-0909 Phone (This is a message line; your call will be returned within 24 hours)
303-940-0308 FAX

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Our mission is to promote the health and well-being of humanity by the development of new medicines through high-quality clinical research and a closely held philosophy of striving for excellence.

To find out about the studies that are currently underway at our office, please see Clinical Trials.

Western States Clinical Research Inc. specializes in research studies related to gastroenterology, asthma and allergy, pulmonology, internal medicine, ophthalmology and dermatology. Our website contains information for physicians, pharmaceutical companies and individuals interested in participating in clinical research.

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