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

NCT03442244 | Completed Phase 1

• 1 other identifier: LP0053-1007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

  Up to Day 4

• Photo irritation

  Positive ratios calculated from the photo irritation scores

  Up to Day 4

Study Arms (2)

LEO 90100 foam

EXPERIMENTAL

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

Drug: LEO 90100 foam

Vehicle foam

PLACEBO COMPARATOR

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

Drug: Vehicle of LEO 90100 foam

Interventions

LEO 90100 foam DRUG

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

LEO 90100 foam

Vehicle of LEO 90100 foam DRUG

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

Vehicle foam

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent has been obtained.
• Healthy Japanese male subjects.
• Aged 20 to 40 years inclusive.

You may not qualify if:

• Body Mass Index outside the range 18-25 kg/m²
• Use of any medication (systemic or topical) within 2 weeks of Day 1.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Medical Co. LTA HAKATA clinic

Fukuoka, Japan

Location

Study Officials

• Study Director

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 22, 2018
• Study Start: January 30, 2018
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: February 24, 2025

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)