A Phase 1 interventional study of LEO 90100 foam and Dovobet® ointment in Healthy, sponsored by LEO Pharma. Completed at 1 site in Japan. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by LEO Pharma · Phase 1, Interventional, and Other
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.
Exclusion Criteria:
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
Drug: LEO 90100 foam
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
Drug: Dovobet® ointment
A foam formulation of the active comparator Dovobet® ointment
Ointment formulation containing same active ingredients as LEO 90100 foam
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.
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.
Time frame: 2, 4, 6, 8, 12 and 24 hr after drug application.
Safety data - number of adverse events
Number of adverse events
Time frame: up to 15 Days after drug application
Plan to share: No
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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LEO Pharma