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The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel.
The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriol plus betamethasone dipropionate gel (LEO 80185) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The proportions of patients who experience adverse drug reactions and the proportion of patients who experience adverse events of concern associated with long-term topical corticosteroid use on the scalp during the study |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of post-baseline satisfactorily controlled assessments according to the Investigators' Global Assessment of disease severity during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| T A Luger, Dr. med. | Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de Dermatologie | Moncton | E1C 8X3 | Canada | |||
| Hørsholm Hospital, Dermatological Department |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
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| Hørsholm |
| 2970 |
| Denmark |
| Hôpital Nord, Service de Dermatologie | Saint-Etienne | 42055 | France |
| Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten | Münster | 48179 | Germany |
| Monklands Hospital, Department of Dermatology | Airdrie | ML6 6JS | United Kingdom |