Dermatopharmacokinetic Trial of LEO 90100 Foam

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LEO 90100 foam; Drug: Dovobet® ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03476746

LP0053-1417

Details and patient eligibility

About

This is a phase 1, single centre trial in Japanese healthy male subjects comparing the amount of active ingredients of LEO 90100 foam and Dovobet® ointment in the stratum corneum.

Enrollment: 58 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese male subjects, aged 20 to 40 years inclusive

Exclusion criteria

• Body Mass Index outside the range 18-25 kg/m²
• Use of any medication (systemic or topical) within 2 weeks of Day 1.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

LEO 90100 foam

Experimental group

Description:

LEO 90100 foam (containing calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g). Pilot part: 6 single applications of LEO 90100 foam on Day 1 (for 12 sites in total). Pivotal part: To be decided based on the result of the pilot part

Treatment:

Drug: LEO 90100 foam

Dovobet® ointment

Active Comparator group

Description:

Pilot part: 6 single applications of Dovobet® ointment on Day 1 (for 12 sites in total). Pivotal part: To be decided based on the result of the pilot part

Treatment:

Drug: Dovobet® ointment