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The purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.
The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriol plus betamethasone dipropionate (LEO80185 gel) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| - Total sign score at week 8 | ||
| - Score for scaliness, redness and thickness at week 8 | ||
| - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 2 and 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter van de Kerkhof, MD | Universitair Medisch, Afdeling Dermatologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie | Leuven | BE-3000 | Belgium | |||
| Innovaderm Research Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19067709 | Derived | van de Kerkhof PC, Hoffmann V, Anstey A, Barnes L, Bolduc C, Reich K, Saari S, Segaert S, Vaillant L. A new scalp formulation of calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial. Br J Dermatol. 2009 Jan;160(1):170-6. doi: 10.1111/j.1365-2133.2008.08927.x. Epub 2008 Nov 25. |
| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
| C011175 | betamethasone-17,21-dipropionate |
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| - Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8 |
| - Evaluation of Adverse Events |
| - Evaluation of Laboratory Data |
| Montreal |
| Quebec |
| H2K 4L5 |
| Canada |
| Policlinic of Dermatology, Medical Reception Centre | Turku | SF-20100 | Finland |
| Hôpital Trousseau, Service de Dermatologie CHU Tours | Tours | F-37044 | France |
| Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie | Göttingen | D-37075 | Germany |
| Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie | Nijmegen | NL-6525 | Netherlands |
| Royal Gwent Hospital, Department of Dermatology | Newport | NP20 2UB | United Kingdom |