LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris
This study has been completed.
Information provided by (Responsible Party):
First received: May 28, 2013
Last updated: December 18, 2013
Last verified: December 2013
The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.
Drug: LEO 90100
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris|
Resource links provided by NLM:
Further study details as provided by LEO Pharma:
Primary Outcome Measures:
- Treatment Success according to IGA [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4.
Secondary Outcome Measures:
- Psoriasis Area Severity Index (a measure combining redness, thickness, scaliness and extent) assessed at week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]m-PASI at Week 4.
- Psoriasis Area Severity Index (a measure combining redness, thickness, scaliness and extent) assessed at week 1 [ Time Frame: 1 week ] [ Designated as safety issue: No ]m-PASI at Week 1.
|Study Start Date:||June 2013|
|Study Completion Date:||November 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: LEO 90100
|Drug: LEO 90100|
Placebo Comparator: Vehicle
Contacts and Locations