Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

October 16, 2022

Study Completion Date

October 16, 2022

Conditions
Atopic DermatitisAtopic Dermatitis EczemaAtopic RashRashPruritusUrticariaUrticaria ChronicPsoriasisPsoriasis VulgarisSkin RashSkin InflammationEczema
Interventions
DRUG

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."

Trial Locations (1)

1217

BCT Ltd., Dhaka

All Listed Sponsors
collaborator

VidiLife Clinical Research Associate

UNKNOWN

lead

OrchestratePharma GmbH

INDUSTRY