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This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to investigate the occurence and the time to relapse and occurence of rebound after discontinuation of the investigational products. Only subjects with "controlled disease" will be considered for this observation phase of the study. "Controlled disease" is defined as "Clear" or "Almost Clear" severity category based on Investigator's global assessment (IGA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
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| 2 | Active Comparator |
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| 3 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcipotriol and betamethasone (LEO 80185 gel) | Drug | Once daily application |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8 | Week 8 |
| Measure | Description | Time Frame |
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| Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity at Week 4 | Week 4 | |
| The Percentage Change in PASI From Baseline to Week 8 | PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Langley, MD | Eastern Canada Cutaneous Research Associates Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Canada Cutaneous Research Associates Ltd. | Halifax | Nova Scotia | B3H 1Z4 | Canada |
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| Label | URL |
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| Clinical Trials at LEO Pharma | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcipotriol Plus Betamethasone Dipropionate Gel | Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks |
| FG001 | Tacalcitol Ointment | Tacalcitol Ointment for up to 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| LEO 80185 vehicle |
| Drug |
Once daily application |
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| Tacalcitol ointment | Drug | Once daily application |
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| Baseline, Week 4 and 8 |
| Subjects With Relapse During the Study | Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit | Week 8-16 |
| Subjects With Rebound During the Study | Week 8-16 |
| FG002 | Gel Vehicle | Gel Vehicle for up to 8 weeks |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcipotriol Plus Betamethasone Dipropionate Gel | Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks |
| BG001 | Tacalcitol Ointment | Tacalcitol Ointment for up to 8 weeks |
| BG002 | Gel Vehicle | Gel Vehicle for up to 8 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8 | Posted | Number | Participants | Week 8 |
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| Secondary | Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity at Week 4 | Posted | Number | participants | Week 4 |
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| Secondary | The Percentage Change in PASI From Baseline to Week 8 | PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst). | Posted | Number | Percent change in PASI score | Baseline, Week 4 and 8 |
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| Secondary | Subjects With Relapse During the Study | Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit | Posted | Number | participants | Week 8-16 |
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| Secondary | Subjects With Rebound During the Study | Posted | Number | participants | Week 8-16 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcipotriol Plus Betamethasone Dipropionate Gel | Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks | 0 | 182 | 25 | 182 | ||
| EG001 | Tacalcitol Ointment | Tacalcitol Ointment for up to 8 weeks | 4 | 184 | 28 | 184 | ||
| EG002 | Gel Vehicle | Gel Vehicle for up to 8 weeks | 1 | 91 | 10 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anders Rhod Larsen, Scientific Advisor | LEO Pharma | +4572262990 | anders.larsen@leo-pharma.com |
| ID | Term |
|---|---|
| C055085 | calcipotriene |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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