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A Phase I, Single-Center, Double-Blind, Randomized Safety, Tolerability, and Dermal Reactogenicity Study of Higher Doses of PDC-APB in Healthy Volunteers With a History of Contact Dermatitis Due to Poison Ivy Exposure

Phase 1, Double- Blind Study, 15 week study, Patch test and Vaccine Injection, Males/Females 18-65 years old with history of urushiol exposure. The rash or allergic contact dermatitis of poison ivy is recognized as occurring after the exposure to the urushiol oil which is found in the leaves of poison ivy, oak and sumac. Currently there is no preventative treatment for contact dermatitis. The purpose of this study is to find out if the vaccine, PDC-APB can help with the prevention of contact dermatitis.
Amy Longenecker at alongenecker@pennstatehealth.psu.edu or 717-531-5136
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18 year(s) or older
This study is also accepting healthy volunteers
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Inclusion Criteria:
Documented history of Poison Ivy (urushiol) exposure with a rash
Willing to follow all study instructions
Attend all study visits
Exclusion Criteria:
use of certain medications not allowed; study coordinator will provide more information
Positive test result of HIV, Hepatitis B or Hepatitis C
Participation in an investigational drug or device study within 30 days prior to screening
There are over the counter medications that are not permitted during the study participation, the study coordinator will discuss the list during the screening process.
Skin Conditions
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Location
Hershey, PA