Dermatopharmacokinetic Trial of LEO 90100 Foam
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: July 1, 2018
Interventions
- Drug: LEO 90100 foam
- A foam formulation of the active comparator Dovobet® ointment
- Drug: Dovobet® ointment
- Ointment formulation containing same active ingredients as LEO 90100 foam
Arms, Groups and Cohorts
- Experimental: 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
- Active Comparator: 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
Clinical Trial Outcome Measures
Primary Measures
- 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.
- Time Frame: 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 Measures
- Safety data – number of adverse events
- Time Frame: up to 15 Days after drug application
- Number of adverse events
Participating in This Clinical Trial
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.
Gender Eligibility: Male
Minimum Age: 20 Years
Maximum Age: 40 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- LEO Pharma
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Study Director, Study Director, LEO Pharma
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