Healthy
Conditions
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.
Interventions
DRUGLEO 90100 foam
A foam formulation of the active comparator Dovobet® ointment
Ointment formulation containing same active ingredients as LEO 90100 foam
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A single application of LEO 90100 foam and Dovobet® ointment will be applied to multiple test sites on the innerside of both arms of trial subjects. The trial consists of 2 parts. The first part, (pilot part) will evaluate the pharmacokinetic profile of LEO 90100 foam and Dovobet® ointment by measuring the amount of each of the active ingredients in the stratum corneum and determine conditions for the second part of the trial. The second part (pivotal part) will compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 90100 foam and Dovobet® ointment. The sample size and the number of application sites in the pivotal part will be determined based on the results of the pilot part.
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Safety data - number of adverse events | up to 15 Days after drug application | Number of adverse events |
Countries
Japan
Outcome results
None listed