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

Phase 1

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: LEO 90100 foam; Drug: Vehicle of LEO 90100 foam

• Registration Number: NCT03442244
• Lead Sponsor: LEO Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-29
• Study Start: 2018-01-30
• Study First Submitted QC: 2018-02-15
• Primary Completion: 2018-02-20
• Study Completion: 2018-02-20
• Study First Posted: 2018-02-22
• Status Verified: 2019-12
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LEO 90100 foam	LEO 90100 foam	Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner LEO 90100 foam contains Calcipotriol hydrate 52.2 μg/g (equivalent to 50.0 μg/g calcipotriol) plus Betamethasone dipropionate 0.643 mg/g
Vehicle foam	Vehicle of LEO 90100 foam	Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner. Foam vehicle does not contain active ingredients

Primary Outcome Measures

Name	Time	Method
Skin irritation	Up to Day 4	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
Photo irritation	Up to Day 4	Positive ratios calculated from the photo irritation scores

Trial Locations

Locations (1)

Medical Co. LTA HAKATA clinic; 🇯🇵 Fukuoka, Japan