Skin Irritation of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects

LEO Pharma20 enrolled

Overview

This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Psoriasis Vulgaris

Interventions

LEO 90100 foamDRUG

Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back

Vehicle of LEO 90100 foamDRUG

Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Signed informed consent has been obtained. * Healthy Japanese male subjects. * Aged 20 to 40 years inclusive. Key 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.

Locations (1)

Medical Co. LTA HAKATA clinic

Fukuoka, Japan

Outcomes

Primary Outcomes

Skin irritation

Skin irritation measured as skin irritation index (summation of clinical scores \[ranging from no reaction to blisters\] from 49 hrs to 72 hrs after aplication) divided by total number of skin irritation assessments

Time frame: Up to Day 4

Photo irritation

Positive ratios calculated from the photo irritation scores

Time frame: Up to Day 4

Data from ClinicalTrials.gov

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