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

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442244
• Other study ID #: LP0053-1007
• Status: Completed
• Phase: Phase 1
• Start date: January 30, 2018
• Est. completion date: February 20, 2018

Study information

• Verified date: December 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO 90100 foam
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
Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back

Locations

Country	Name	City	State
Japan	Medical Co. LTA HAKATA clinic	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Photo irritation	Positive ratios calculated from the photo irritation scores	Up to Day 4