Conditions: Tinea Pedis Tinea Cruris
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.

Detailed description:

Arms:
arm 1: Participants will receive 1 oral capsule of omeprazole 40 milligrams (mg) on Day 1 and Day 8. Participants will also receive luliconazole cream 1% to cover the entire affected surface areas and adjacent areas once daily in the morning on Day 2 (24 hours after initial omeprazole dosing) through Day 8.

Interventions: intervention 1: Omeprazole 40 mg intervention 2: Luliconazole Cream 1%
Intervention descriptions: intervention 1: Oral capsule to be taken as per the instructions regarding proper dosing technique. intervention 2: Topical cream to be applied as per the instructions regarding proper study drug application technique.

Protocol document: