Back to resultsSkin Irritation of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
LEO 90100 foam
Vehicle of LEO 90100 foam
Sponsored by
About this trial
This is an interventional other trial for Psoriasis Vulgaris
Eligibility Criteria
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.
Sites / Locations
- Medical Co. LTA HAKATA clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LEO 90100 foam
Vehicle foam
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Photo irritation
Positive ratios calculated from the photo irritation scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03442244
Brief Title
Skin Irritation of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
Official Title
Skin Irritation Trial of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
February 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 90100 foam
Arm Type
Experimental
Arm Description
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
Arm Title
Vehicle foam
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
LEO 90100 foam
Intervention Description
Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back
Intervention Type
Drug
Intervention Name(s)
Vehicle of LEO 90100 foam
Intervention Description
Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back
Primary Outcome Measure Information:
Title
Skin irritation
Description
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
Time Frame
Up to Day 4
Title
Photo irritation
Description
Positive ratios calculated from the photo irritation scores
Time Frame
Up to Day 4
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Medical Co. LTA HAKATA clinic
City
Fukuoka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Skin Irritation of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
We'll reach out to this number within 24 hrs