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NCT03476746 Clinical Trial

Dermatopharmacokinetic Trial of LEO 90100 Foam

Healthy Clinical Trial

Official title:
Dermatopharmacokinetic Trial of LEO 90100 Foam

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03476746
Other study ID # LP0053-1417
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 20, 2018
Est. completion date July 1, 2018

Study information
Verified date August 2018
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• LEO 90100 foam
A foam formulation of the active comparator Dovobet® ointment
• Dovobet® ointment
Ointment formulation containing same active ingredients as LEO 90100 foam

Locations
Country Name City State
Japan Investigational site Fukuoka

Sponsors (1)
Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 2, 4, 6, 8, 12 and 24 hr after drug application.
Secondary Safety data - number of adverse events Number of adverse events up to 15 Days after drug application
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