Pilot Study to Test Uniformity of Transdermal Drug Delivery to the Breast Using Diclofenac Epolamine as a Model
This is a randomized study where participants in group 1 will apply the diclofenac epolamine
patch to the breast and participants in group 2 will apply the same drug to her abdomen.
Participants are instructed to apply a new patch every 12 hours for 3 days. Total
participation in this study will be for three days, ending on the day of surgery. On the day
of surgery, participants will have blood drawn to measure the level of diclofenac epolamine
in the body, and the final patch will be removed.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen
The primary objective of this protocol will demonstrate that diclofenac epolamine patch applied to the skin of the breast for three days (1, 2) prior to surgery will result in significantly higher drug concentrations in the breast than the same dose applied to the abdominal skin for the same duration of time.
after 3 days of treatment prior to surgery
Seema Khan, MD
United States: Institutional Review Board
|Northwestern University||Chicago, Illinois 60611|