A randomized, parallel group, open-label, multicenter study to assess the potential for adrenal suppression and systemic drug absorption following multiple dosing with DFD-01 (betamethasone diproprionate) spray, 0.05% in adolescent subjects with moderate to severe plaque psoriasis
Natasha Mesinkovska, MD, PhD
The purpose of this study is to evaluate the use of DFD-01 (betamethasone diproprionate) spray, 0.05%, to treat adolescent subjects with moderate to severe plaque psoriasis.
Research participants who have been diagnosed with plaque psoriasis and are 12 to 16.9 years of age at the time of randomization.
The total study duration, not including the screening visit (the initial visit to determine whether this study is appropriate for you), is either 43 to 57 days, plus any wash-out you may need (a period of time that you would stop taking medications that are not allowed during the entire study).
Study participants will be paid $50 at specified time points over the course of the study. There are six visits for 29-day treatment arm and five visits for 15-day treatment arm. Total compensation for participation in the entire study is $300 for 29-day treatment arm and $250 for 15-day treatment arm. If you decide to withdraw from the study or are withdrawn by the research team, you will receive compensation for the visits and/or procedures that you have completed. Qualified research participants will receive study-related examinations and topical treatment to apply on their skin twice a day at no charge.
DFD-01 (betamethasone diproprionate)
Patty Summerville, clinical research coordinator, Department of Dermatology