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| Principal Investigator: | Vincent DeLeo, MD | |
| Co-investigators: | Maryann Mikhail, MD Marcelyn K.Coley, MD Ramon Solhkhah, MD |
|
| Time frame of study: | 2.5 years | |
| Time frame of participation: | 88 weeks (16 weeks run-in + 24 weeks therapy + 48 weeks follow up) | |
| Number of participants needed: | 10 | |
| Location of Study: | St. Luke’s Hospital |
|
| Contact Name, Number & Email: | Evelyn Koestenblatt (212) 523-4511 EKoesten@chpnet.org |
Summary:
Approximately 600 subjects from 90 centers in the USA will
participate in this randomized, double blind, placebo-controlled multicenter
study. Once the subject qualifies at the screening they will enter a run-in
period of up to 16 weeks. During this time subjects will receive standard
skin care and treatment with potent topical corticosteroids. Irritants
and allergens will be tested for, identified and avoided by the subject.
If subjects are not helped by this treatment, they will be randomized
to trial treatment for up to 24 weeks of oral treatment with the study
medication.
Criteria for
Participation:
- Male and female patients 18 – 75 years
old
- Severe, chronic hand eczema lasting over 6 months, refractory to topical
therapy.
- Women of childbearing potential must be willing to commit to using 2
effective forms of contraception simultaneously.