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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriol plus betamethasone dipropionate (LEO 80185) gel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Fleming, MD | Ninewells Hospital and Medical School, Ninewells, Dundee, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Guenther Dermatology Research Centre | London | Ontario | N6A3H7 | Canada | ||
| Universitätsklinikum Leipzig |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
| C011175 | betamethasone-17,21-dipropionate |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Patients with "clear" or "very mild" disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8. |
| Leipzig |
| 04103 |
| Germany |
| Waterford Regional Hospital | Waterford | Ireland |
| Läkarhuset Vällingby | Vällingby | 16268 | Sweden |
| Ninewells Hospital and Medical School | Dundee | Scotland | DD1 9SY | United Kingdom |