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The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all eligible patients | Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daivobet® Gel | Drug | Once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance. |
| Measure | Description | Time Frame |
|---|---|---|
| The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. | Number of exacerbations and relapses during one year observation time | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | 6--point verbal rating scale | Baseline |
| PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Psoriasis vulgaris visiting their attending dermatologist in the primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Rosenberg, PD Dr. med. | private practise, D- 49078 Osnabrück, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PD Dr. med. Rosenbach | Osnabrück | Lower Saxony | 49078 | Germany |
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The study was conducted in Germany between 8th September 2011 (retrospective data) and 15th May 2014. The planned observation period for each patient was about 12 months.
The total planned sample size of this NIS was 1000 (analysable 750) patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Eligible Patients | Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Eligible Patients | Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. | Number of exacerbations and relapses during one year observation time | Participants with at least one observation after baseline | Posted | Count of Participants | Participants | 1 year |
|
|
1 year
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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 | All Eligible Patients | Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug ineffective | General disorders | MedDRA (17.0) | Non-systematic Assessment |
Mean duration of observation per patients: Mean (SD): 40.47 (17.60) weeks.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tobias Anger, Medical Advisor | LEO Pharma GmbH | +49 610 220 1258 | TANDE@leo-pharma.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 1 year |
| Side Effects | Number of participants with serious and non-serious adverse drug reactions. | 1 year |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Affected body surface area (BSA) at admission | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | 6--point verbal rating scale | Participants with at least one severity assessment after baseline | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5) | Participants with at least one observation after baseline (last observation carried forward) | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Side Effects | Number of participants with serious and non-serious adverse drug reactions. | All enrolled | Posted | Number | Number of events recorded | 1 year |
|
|
|
| 2 |
| 561 |
| 3 |
| 561 |
| 50 |
| 561 |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Application site pustules | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Sense of oppression | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Follikulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Application site dryness | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
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| Moderate |
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| Severe |
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| Very severe |
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| Symptoms moderate |
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| Symptoms severe |
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| Symptoms very severe |
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| Title |
|---|
| Measurements |
|---|
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| Serious, causality not assessible |
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| Non-serious, causal relation probable |
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| Non-serious, causal relation possible |
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| Non-serious, not related |
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| Non-serious, causality not assessible |
|