12
Participants
Start Date
April 1, 2022
Primary Completion Date
October 16, 2022
Study Completion Date
October 16, 2022
Fexofenadine Hydrochloride Topical Lotion 1% (OP2101)
"Intervention:~The amount of study lotion (OP2101) used is 11 grams per subject, equivalent to 22 fingertip units (FTU). The lotion is applied to the subject on back and front of the trunk, both hands (palm and back) and both arms. An SOP for handling and application of the lotion ensures the 11 grams covers 54% of the body surface area (BSA) evenly without residue.~Comment:~The treatment is single-dose and single-treatment. The FTU is used to standardize the amount of cream being applied in clinical research. It is also used in clinical practice and hence connects the objectiveness of the trial to the clinical situation."
BCT Ltd., Dhaka
VidiLife Clinical Research Associate
UNKNOWN
OrchestratePharma GmbH
INDUSTRY