Back to resultsA Vasoconstriction Study With LEO 90100
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
LEO 90100 Aerosol, foam
Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle
LEO 90100 Aerosol, foam, vehicle
Daivobet® ointment
Dermovate® cream
Synalar® ointment
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
- Healthy male or female volunteers, 18 to 50 years old, both inclusive
Exclusion Criteria:
- Female subjects who are pregnant or who are breast feeding.
- Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)
Sites / Locations
- CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LEO 90100
Arm Description
Outcomes
Primary Outcome Measures
Visual assessment of skin blanching (visual score (VS))
Visual Assessment of Skin Blanching on scores 0 to 4
Secondary Outcome Measures
Change from baseline in colorimetric parameter a* (the red/green balance) at each time point
Change from baseline in colorimetric parameter. AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change
Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*)
AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01946386
Brief Title
A Vasoconstriction Study With LEO 90100
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar® ointment and LEO 90100 vehicle using a human skin blanching test.
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
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 90100
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LEO 90100 Aerosol, foam
Intervention Description
The products will be applied on 6 test sites (according to random assignment to specific test sites predetermined on their anterior face of forearms) for 6 hours
Intervention Type
Drug
Intervention Name(s)
Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle
Intervention Type
Drug
Intervention Name(s)
LEO 90100 Aerosol, foam, vehicle
Intervention Type
Drug
Intervention Name(s)
Daivobet® ointment
Intervention Type
Drug
Intervention Name(s)
Dermovate® cream
Intervention Type
Drug
Intervention Name(s)
Synalar® ointment
Primary Outcome Measure Information:
Title
Visual assessment of skin blanching (visual score (VS))
Description
Visual Assessment of Skin Blanching on scores 0 to 4
Time Frame
06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Secondary Outcome Measure Information:
Title
Change from baseline in colorimetric parameter a* (the red/green balance) at each time point
Description
Change from baseline in colorimetric parameter. AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change
Time Frame
06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Title
Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*)
Description
AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change
Time Frame
06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
Healthy male or female volunteers, 18 to 50 years old, both inclusive
Exclusion Criteria:
Female subjects who are pregnant or who are breast feeding.
Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)
Facility Information:
Facility Name
CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie
City
Nice
ZIP/Postal Code
06202
Country
France
12. IPD Sharing Statement
Citations:
Citation
Queille-Roussel C, Bang B, Clonier F, Lacour JP. Phase I evaluation of the vasoconstrictor potential of an innovative fixed combination calcipotriene plus betamethasone dipropionate aerosol foam versus other corticosteroid psoriasis treatments. J Am Acad Dermatol. 2015:72 Suppl 1;AB243 (P915).
Results Reference
result
Learn more about this trial
A Vasoconstriction Study With LEO 90100
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