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The purpose of this study is to evaluate whether once daily 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, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.
The primary outcome is the proportion of patients with absence of disease or 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 |
|---|---|---|
| Overall disease severity according to investigator's assessment at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Total sign score at week 8 | ||
| Score for scaliness, redness and thickness at week 8 | ||
| Extent of scalp psoriasis at week 8 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregor Jemec, MD | Roskilde Hospital, Division of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain | Québec | G1V 4X7 | Canada | |||
| Roskilde Hospital, Division of Dermatology |
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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 |
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| Overall disease severity according to investigator's assessment at week 2 and 4 |
| Overall disease severity according to patients at week 8 |
| Adverse events |
| Laboratory data |
| Roskilde |
| 4000 |
| Denmark |
| HĂ´pital de l'Archet, Service de Dermatologie | Nice | 06202 | France |
| Hudlegekontoret | Sandvika | 1338 | Norway |
| Hospitais da Universidade de Coimbra, Servico de dermatologia | Coimbra | 3000-075 | Portugal |
| Hospital Virgen de la Macarena, Servicio de DermatologĂa | Seville | 41009 | Spain |
| Akademiska Sjukhuset, Hudkliniken | Uppsala | 751 85 | Sweden |
| Western Infirmary, Dermatology Department | Glasgow | G11 6NT | United Kingdom |