Skip to main content
OpenTrials
Completed

NCT Number: NCT03442244

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Vulgaris

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Medical Co. LTA HAKATA clinic

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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

Primary outcomes

  1. Skin irritation

    Time frame: 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

  2. Photo irritation

    Time frame: Up to Day 4

    Positive ratios calculated from the photo irritation scores

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2018
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.