The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
SINGLE
Enrollment
24
once daily application, 3 weeks
once daily application, 3 weeks
once daily application, 3 weeks
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière
Nice, France
Change in the Total Clinical Score From Baseline to Day 22
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)
Time frame: Baseline to Day 22
Change in Erythema From Baseline to Day 22
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to Day 22
Change in Infiltration From Baseline to Day 22
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to Day 22
Change in Scaling From Baseline to Day 22
Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to Day 22
Change in Lesion Thickness From Baseline to Day 22
Change in total skin thickness measured by ultrasound from baseline to end of treatment
Time frame: Baseline to Day 22
Change in Skin Thickness From Baseline to Day 22
Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment
Time frame: Baseline to Day 22
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once daily application, 3 weeks
once daily application, 3 weeks
once daily application, 3 weeks