Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
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|ClinicalTrials.gov Identifier: NCT00263718|
Recruitment Status : Completed
First Posted : December 9, 2005
Last Update Posted : March 26, 2015
The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks.
The primary response criterion is the number of patients with controlled disease at week 8.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris||Drug: Calcipotriol plus betamethasone dipropionate (LEO 80185) gel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle and the Gel Vehicle Alone in Psoriasis Vulgaris|
|Study Start Date :||December 2005|
|Estimated Study Completion Date :||May 2006|
- Patients with "controlled disease" (minimal or clear and at least two steps change from baseline) according to the investigators' global assessment of disease severity at week 4 and week 8.
- The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8.
- Patients with "controlled disease" according to the investigators' global assessment of disease severity at week 1, 2, and 6.
- Patients with "clear" or "very mild" disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8.
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): NCT00263718
|The Guenther Dermatology Research Centre|
|London, Ontario, Canada, N6A3H7|
|Leipzig, Germany, 04103|
|Waterford Regional Hospital|
|Vällingby, Sweden, 16268|
|Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Principal Investigator:||Colin Fleming, MD||Ninewells Hospital and Medical School, Ninewells, Dundee, UK|