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The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all patients apply all products | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daivobet® ointment | Drug | Once daily application 6 days a week for 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Baseline and 3 weeks |
| The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Baseline and 3 weeks |
| The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Baseline and 3 weeks |
| The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Baseline and 3 weeks |
| The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Baseline and 3 weeks |
| The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment |
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Inclusion Criteria: (in summary)
Exclusion Criteria: (in summary)
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma Investigational Site | Saint Quentin Yvelines Cedex | 78054 | France |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Treated | Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Betnovat® ointment | Drug | Once daily application 6 days a week for 3 weeks |
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| Diprosalic ointment | Drug | Once daily application 6 days a week for 3 weeks |
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| Dermovat ointment | Drug | Once daily application 6 days a week for 3 weeks |
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| Elocon ointment | Drug | Once daily application 6 days a week for 3 weeks |
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| Daivobet® ointment vehicle | Drug | Once daily application 6 days a week for 3 weeks |
|
The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)
| Baseline and 3 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated | Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Posted | Mean | Standard Error | Scores on a scale | Baseline and 3 weeks |
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| Primary | The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Posted | Mean | Standard Error | Scores on a scale | Baseline and 3 weeks |
|
| |||||||||||||||||||||||||||
| Primary | The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Posted | Mean | Standard Error | Scores on a scale | Baseline and 3 weeks |
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| Primary | The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Posted | Mean | Standard Error | Scores on a scale | Baseline and 3 weeks |
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| Primary | The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Posted | Mean | Standard Error | Scores on a scale | Baseline and 3 weeks |
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| Primary | The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment | The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) | Posted | Mean | Standard Error | Scores on a scale | Baseline and 3 weeks |
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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 | Patients Treated | Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. | 0 | 24 | 0 | 24 |
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LEO retains the right to publish the results of this clinical trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Torsten Skov, Senior Medical Advisor | LEO Pharma | +45 20 73 62 94 | torsten.skov@leo-pharma.com |
| >=68 years |
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