A Psoriasis Plaque Test on LEO 27989 Ointment and Calcipotriol Plus LEO 27989 Ointment in Patients With Psoriasis Vulgaris
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|ClinicalTrials.gov Identifier: NCT01297166|
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : October 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris||Drug: LEO 27989 ointment Drug: Calcipotriol plus LEO 27989 ointment Drug: Calcipotriol ointment Drug: Vehicle ointment||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Psoriasis Plaque Test on LEO 27989 Ointment and Calcipotriol Plus LEO 27989 Ointment in Patients With Psoriasis Vulgaris.|
|Study Start Date :||February 2011|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
|Experimental: LEO 27989 ointment||
Drug: LEO 27989 ointment
once daily application, 3weeksDrug: Calcipotriol plus LEO 27989 ointment
once daily application, 3weeksDrug: Calcipotriol ointment
once daily application, 3weeksDrug: Vehicle ointment
once daily application, 3weeks
- Absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) at end of treatment compared to baseline. [ Time Frame: 3 weeks ]TCS range from 0 (all symptoms absent) to 9 (all symptoms severe)
- Clinical sympton scores [ Time Frame: 3 weeks ]
Absolute change in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits compared to baseline.
Change in Total Clinical Score (TCS) at individual visits compared to baseline.
- Lesion thickness [ Time Frame: 3 weeks ]Change in lesion thickness measured by ultrasound at each assessment compared to baseline.
- Immunohistochemical and histologic scoring of biopsy material [ Time Frame: 3 weeks ]
- Intra-subject variability [ Time Frame: 3 weeks ]The intra-subject variability of changes from baseline to end of treatment of TCS and skin thickness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297166
|Principal Investigator:||Catherine Queille-Roussel, MD||Centre de Pharmacologie Clinique Applique a la Dermatologie|