Study for a New Topical Medicine
Date: 09/27/2012
Galderma is conducting a study for a new topical medicineExploratory Study to Assess the Safety and Efficacy of CD5789 in Subjects with Hereditary Palmoplantar Keratodermas
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| Amy Paller, MD |
Galderma is sponsoring a clinical study to investigate a new topical medication for patients with hereditary palmoplantar keratodermas (thickening of the palms and soles) at Northwestern University in Chicago, Illinois, with an expert in the ichthyosis. This study is open to those meeting the criteria listed below, which would includes those who have palmoplantar keratoderma in association with ichthyosis. Many of those affected with ichthyosis have thickening on their feet. This new cream might help with the thickening on the feet (which is what is being studied), and perhaps in the future on the hands and elsewhere. Another study will follow specifically to try the cream for lamellar ichthyosis, but the individuals with lamellar ichthyosis can participate in both studies per Galderma. The company will compensate anyone, in addition to the chance to try the new cream. One thing to be aware of: if you are taking an oral retinoid, you cannot be on the study and, in fact, you would have to be off of it for 6 months to be eligible. During the first month or two of the study, only adult males and women who are not able to have children right now are eligible, but if you are a woman of childbearing age and interested, please let the investigators know: it is likely that the study for the feet will be extened to all adult women shortly, and all adult women will be eligible for the trial of lamellar ichthyosis.
We are looking for:
- Females of non-childbearing potential or males between 18 and 65 years of age with a diagnosis of hereditary palmoplantar keratoderma; must be able to be in the Chicago area for 6-8 weeks for cream application and weekly visits for 6 weeks.
Study Involves:
- Weekday application of study medication for 6 weeks by a home health agency
- Weekly clinic visits for 6 weeks
- Laboratory and ECG assessments
If you decide to take part you will receive:
- Study related medical evaluation, including physical exam and test results
- Study medication at no cost
- Financial compensation for qualified participants
For additional information, contact the site clinical coordinator:
Northwestern University: 312.695.0287
Children’s Memorial Hospital: 312.227.6484
Principal Investigator:
Amy S. Paller, MD - Northwestern University, Chicago, Illinois
