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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002079-11 | EudraCT Number |
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To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249 ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 124249 ointment | Active Comparator | Twice daily cutaneous application for 8 weeks |
|
| LEO 124249 ointment vehicle | Placebo Comparator | Twice daily cutaneous application for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 124249 ointment | Drug | Ointment |
| |
| LEO 124249 ointment vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment) | Treatment success according to the PGA is defined as: Subjects having mild disease at baseline must achieve clear. Subjects having moderate or severe disease at baseline must achieve clear or almost clear | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Eczema Severity Index (HECSI) at visit 6 | 56 days | |
| Subjects with treatment success according to the Patient's Global Assessment of disease severity (PaGA) at visit 6 (End of Treatment) | Treatment success according to the PaGA is defined as: Subjects having very mild or mild disease at baseline must achieve clear. Subjects having moderate or severe disease at baseline must achieve clear or very mild |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margitta Worm, Prof Dr | Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie | Berlin | 10117 | Germany |
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| Label | URL |
|---|---|
| LEO Pharma Clinical Trials | View source |
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| Drug |
Ointment vehicle |
|
| 56 days |