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The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 90105 Ointment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 90105 | Drug | Once daily for four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic: Cmax of Betamethasone Dipropionate | The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined. | Day 1 |
| Pharmacokinetic: Cmax of Betamethasone Dipropionate | The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined | Day 7 |
| Pharmacokinetic: Cmax of Betamethasone Dipropionate | The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined | Day 14 |
| Pharmacokinetic: AUClast of Betamethasone Dipropionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined | Day 1 |
| Pharmacokinetic: AUClast of Betamethasone Dipropionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined | Day 7 |
| Pharmacokinetic: AUClast of Betamethasone Dipropionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined | Day 14 |
| Pharmacokinetic: Cmax of Betamethasone 17-propionate |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percentage Change in m-PASI From Baseline to Day 28 | Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease. The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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Prior to treatment at Visit 1, a washout period was completed if the subject was treated or had recently been treated with anti-psoriatic treatments or other relevant medication, as defined by the exclusion criteria. The washout period could last up to a maximum of 4 weeks.
First subject first visit: 09-Jul-2012 Last subject last visit: 30-Oct-2012
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 90105 Ointment | Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 90105 Ointment | Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetic: Cmax of Betamethasone Dipropionate | The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined. | Posted | Mean | Standard Deviation | pg/mL | Day 1 |
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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 | LEO 90105 Ointment | Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical trial disclosure manager | LEO Pharma A/S | 00 45 44 94 58 88 | ctr.disclosure@leo-pharma.com |
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The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
| Day 1 |
| Pharmacokinetic: Cmax of Betamethasone 17-propionate | The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined | Day 7 |
| Pharmacokinetic: Cmax of Betamethasone 17-propionate | The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined | Day 14 |
| Pharmacokinetic: AUClast of Betamethasone 17-propionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined | Day 1 |
| Pharmacokinetic: AUClast of Betamethasone 17-propionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined | Day 7 |
| Pharmacokinetic: AUClast of Betamethasone 17-propionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined | Day 14 |
| Pharmacokinetic: Cmax of Calcipotriol | The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined | Day 1 |
| Pharmacokinetic: Cmax of Calcipotriol | The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined | Day 7 |
| Pharmacokinetic: Cmax of Calcipotriol | The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined | Day 14 |
| Pharmacokinetic: AUClast of Calcipotriol | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined | Day 1 |
| Pharmacokinetic: AUClast of Calcipotriol | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined | Day 7 |
| Pharmacokinetic: AUClast of Calcipotriol | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined | Day 14 |
| Pharmacokinetic: Cmax of MC1080 | The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined | Day 1 |
| Pharmacokinetic: Cmax of MC1080 | The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined | Day 7 |
| Pharmacokinetic: Cmax of MC1080 | The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined | Day 14 |
| Pharmacokinetic: AUClast of MC1080 | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined | Day 1 |
| Pharmacokinetic: AUClast of MC1080. | To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined | Day 7 |
| Pharmacokinetic: AUClast of MC1080. | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined | Day 14 |
| Baseline to Day 28 |
| Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28. | Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28. Investigator global assessment (IGA) is based on the investigator's assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit. | Day 28 |
| Participants |
|
| 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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| Participants |
|
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| Primary | Pharmacokinetic: Cmax of Betamethasone Dipropionate | The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined | Posted | Mean | Standard Deviation | pg/mL | Day 7 |
|
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| Primary | Pharmacokinetic: Cmax of Betamethasone Dipropionate | The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined | Posted | Mean | Standard Deviation | pg/mL | Day 14 |
|
|
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| Primary | Pharmacokinetic: AUClast of Betamethasone Dipropionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 1 |
|
|
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| Primary | Pharmacokinetic: AUClast of Betamethasone Dipropionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 7 |
|
|
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| Primary | Pharmacokinetic: AUClast of Betamethasone Dipropionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 14 |
|
|
|
| Primary | Pharmacokinetic: Cmax of Betamethasone 17-propionate | The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined | Posted | Mean | Standard Deviation | pg/mL | Day 1 |
|
|
|
| Primary | Pharmacokinetic: Cmax of Betamethasone 17-propionate | The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined | Posted | Mean | Standard Deviation | pg/mL | Day 7 |
|
|
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| Primary | Pharmacokinetic: Cmax of Betamethasone 17-propionate | The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined | Posted | Mean | Standard Deviation | pg/mL | Day 14 |
|
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|
| Primary | Pharmacokinetic: AUClast of Betamethasone 17-propionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 1 |
|
|
|
| Primary | Pharmacokinetic: AUClast of Betamethasone 17-propionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 7 |
|
|
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| Primary | Pharmacokinetic: AUClast of Betamethasone 17-propionate | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 14 |
|
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| Primary | Pharmacokinetic: Cmax of Calcipotriol | The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined | Posted | Mean | Standard Deviation | pg/mL | Day 1 |
|
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| Primary | Pharmacokinetic: Cmax of Calcipotriol | The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined | Posted | Mean | Standard Deviation | pg/mL | Day 7 |
|
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| Primary | Pharmacokinetic: Cmax of Calcipotriol | The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined | Posted | Mean | Standard Deviation | pg/mL | Day 14 |
|
|
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| Primary | Pharmacokinetic: AUClast of Calcipotriol | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 1 |
|
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| Primary | Pharmacokinetic: AUClast of Calcipotriol | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 7 |
|
|
|
| Primary | Pharmacokinetic: AUClast of Calcipotriol | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 14 |
|
|
|
| Primary | Pharmacokinetic: Cmax of MC1080 | The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined | Posted | Mean | Standard Deviation | pg/mL | Day 1 |
|
|
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| Primary | Pharmacokinetic: Cmax of MC1080 | The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined | Posted | Mean | Standard Deviation | pg/mL | Day 7 |
|
|
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| Primary | Pharmacokinetic: Cmax of MC1080 | The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined | Posted | Mean | Standard Deviation | pg/mL | Day 14 |
|
|
|
| Primary | Pharmacokinetic: AUClast of MC1080 | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 1 |
|
|
|
| Primary | Pharmacokinetic: AUClast of MC1080. | To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 7 |
|
|
|
| Primary | Pharmacokinetic: AUClast of MC1080. | The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined | Posted | Mean | Standard Deviation | h*pg/mL | Day 14 |
|
|
|
| Secondary | Efficacy: Percentage Change in m-PASI From Baseline to Day 28 | Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease. The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 28 |
|
|
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| Secondary | Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28. | Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28. Investigator global assessment (IGA) is based on the investigator's assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit. | Posted | Number | participants | Day 28 |
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| 0 |
| 13 |
| 4 |
| 13 |
| Folliculitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
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LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.