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This is a phase 2a trial testing twice daily administration of LEO 124249 ointment 30 mg/g in the treatment of mild to moderate inverse psoriasis. Patients will be treated for 6 weeks, and the efficacy and safety will be compared with the treatment of LEO 124249 ointment vehicle.
Single country, Multi-center, prospective, randomised, double-blind, 2 arms parallel-group, vehicle-controlled, 6 weeks, phase 2a trial in subjects with mild to moderate inverse psoriasis. LEO 124249 ointment 30 mg/g and LEO 124249 ointment vehicle treatments will be compared with regards to efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 124249 ointment 30 mg/g | Active Comparator | Drug LEO 124249 ointment 30 mg/g twice daily application for 6 weeks, maximum of 1.44 g ointment per day |
|
| LEO 124249 ointment vehicle | Placebo Comparator | LEO 124249 ointment vehicle twice daily application for 6 weeks, maximum of 1.44 g ointment per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 124249 ointment 30 mg/g | Drug |
| ||
| LEO 124249 ointment vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| The total sign score (TSS) at Week 6 (Visit 6) | after 6 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| For PGA, the number of subjects reaching controlled disease at Visit 6 (Week 6) | after 6 weeks of treatment | |
| Score for clinical sign redness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6) | after 6 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Luger, MD | Universitätsklinikum Münster, Klinik fur Hautkrankheiten | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johannes Niesmann | Bochum | 44803 | Germany |
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| Label | URL |
|---|---|
| LEO Pharma Clinical Trials | View source |
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| Other |
|
| Score for clinical sign thickness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6) | after 6 weeks of treatment |
| Score for clinical sign scaliness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6) | after 6 weeks of treatment |
| Size of treatment area of inverse psoriasis at Visit 6 (Week 6) | after 6 weeks of treatment |
| For PaGA, the number of subjects reaching controlled disease at Visit 6 (Week 6) | after 6 weeks of treatment |
| Dermatology Life Quality Index (DLQI) questionnaire at Visit 6 (Week 6) | after 6 weeks of treatment |
| Treatment satisfaction questionnaire for medication (TSQM II) at Visit 6 (Week 6) | after 6 weeks of treatment |
| Subjects assessment of itching (daily assessment in diary of the first 14 days on treatment (between Visits 2 (Start of treatment) to 4 (Week 2), followed by assessments at the following Visits 4 (Week 2) to 6 (Week 6)) | after 6 weeks of treatment |
| Subjects overall assessment of cosmetic acceptability at Visit 6 (Week 6) | after 6 weeks of treatment |
| Evaluation of population steady state pharmacokinetics of LEO 124249 at Visit 3 (Week 1), by sampling of 1 blood sample to get 1 plasma concentration value per patient after 1 weeks treatment | after 6 weeks of treatment |
| Adverse Events | after 6 weeks of treatment |
| Abnormal and clinically significant findings in blood pressure, heart rate, body temperature will be listed | after 6 weeks of treatment |
| Abnormal and clinically significant laboratory parameters will be listed | after 6 weeks of treatment |