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This study aims to assess how the Enstilar® aerosol foam performs in daily real-life practice with regards to effectiveness and convenience of application to psoriasis plaques on body and extremities. In addition the profiles of patients prescribed Enstilar® will be described, and preceeding, concomitant and follow-up management will be mapped. The study will be conducted in about 100 dermatology clinics all over Germany,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enstilar® | Patients with psoriasis vulgaris plaques on body and/or extremities will apply Enstilar® (calcipotriol /betamethasone dipropionate (50 micrograms/g + 0.5 mg/g) cutaneous foam) once daily for up to 4 weeks, according to the approved labelling of Enstilar® in Germany. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enstilar® | Drug | Once daily application of cutaneous foam to plaques on body and/or extremities |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment | 5-point Likert scale | Week 4 |
| Percentage of total body surface area affected | Percentage | 4 weeks |
| Absence of related adverse events (ADR) | Proportion of patients with no ADRs | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Assessment | 5-point Likert scale | 4 weeks |
| PASI 50 | Psoriasis Area and Severity Index | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with psoriasis vulgaris plaques on trunk and/or extremities of at least mild severity for whom topical treatment with Enstilar® is planned
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| Name | Affiliation | Role |
|---|---|---|
| Sascha Gerdes, Dr.med. | Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein, Campus Kiel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein | Kiel | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24354461 | Background | Langley RG, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. The 5-point Investigator's Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015 Feb;26(1):23-31. doi: 10.3109/09546634.2013.865009. Epub 2013 Dec 20. | |
| 8033378 | Background |
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| ID | Term |
|---|---|
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
| C055085 | calcipotriene |
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| PASI 75 | Psoriasis Area and Severity Index | 4 weeks |
| Patient reported itching | 10-point scale | 4 weeks |
| Patient reported sleep loss | 10-point scale | 4 weeks |
| Patient reported erythema | 10-point scale | 4 weeks |
| Patient reported scaling | 10-point scale | 4 weeks |
| Patient reported dry skin | 10-point scale | 4 weeks |
| Patient reported overall treatment satisfaction | 4-point Likert scale | 4 weeks |
| Patient reported satisfaction with effectiveness | 4-point Likert scale | 4 weeks |
| Patient reported satisfaction with tolerability | 4-point Likert scale | 4 weeks |
| Patient reported satisfaction with convenience | 4-point Likert scale | 4 weeks |
| Dermatology Life Quality Index | Standard Quality of Life Questionnaire (DLQI) | 4 weeks |
| Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x. |
| 29502110 | Result | Gerdes S, Krakor M, Anger T, Hutt HJ, Korber A. Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar(R)) in Patients with Plaque Psoriasis under Daily Practice Conditions. Dermatology. 2017;233(6):425-434. doi: 10.1159/000486700. Epub 2018 Mar 2. |