Dermatopharmacokinetic Trial of LEO 90100 Foam
- Registration Number
- NCT03476746
- Lead Sponsor
- LEO Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 58
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LEO 90100 foam LEO 90100 foam 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 Dovobet® ointment Dovobet® ointment 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
- Primary Outcome Measures
Name Time Method The amount of each of the 2 active ingredients, calcipotriol and betamethasone dipropionate, in the stratum corneum obtained by means of tape stripping after application of LEO 90100 foam and Dovobet® ointment. 2, 4, 6, 8, 12 and 24 hr after drug application. Amount (nanogram) of calcipotriol and betamethasone dipropionate in the stratum corneum will be compared between the two formulations by selected time points using an ANOVA model with treatment/formulation as systematic effect.
- Secondary Outcome Measures
Name Time Method Safety data - number of adverse events up to 15 Days after drug application Number of adverse events
Trial Locations
- Locations (1)
Investigational site
🇯🇵Fukuoka, Japan