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

NCT ID: NCT03442244

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2018-02-20

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.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

LEO 90100 foam

Intervention Type: DRUG

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

Vehicle 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

Group Type: PLACEBO_COMPARATOR

Vehicle of LEO 90100 foam

Intervention Type: DRUG

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

Interventions

LEO 90100 foam

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

Intervention Type: DRUG

Vehicle of LEO 90100 foam

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent has been obtained.
• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

LEO Pharma

Locations

Medical Co. LTA HAKATA clinic

Fukuoka, , Japan

Countries

Japan

Other Identifiers

LP0053-1007

Identifier Type: -

Identifier Source: org_study_id