Efficacy and Tolerability of Enstilar® in Daily Practice

Study Overview
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Brief Summary
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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,

Official Title
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Prospective, Observational, Non-interventional, Multicenter Study on the Efficacy and Tolerability of Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients With Plaque Psoriasis Under Daily Practice Conditions

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Enstilar®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Psoriasis vulgaris Lesions on trunk and/or extremities of at least mild severity Treatment with Enstilar® planned Signed informed consent to participate Exclusion Criteria: Enrolled in any interventional clinical trial Ongoing or recent treatment with any systemic psoriasis Ongoing or recent treatment with UV-therapy Ongoing or previous treatment with Enstilar® Psoriasis of scalp only Other forms of psoriasis, e.g. erythrodermic or pustular psoriasis More than 30% of surface area affected by psoriasis Any contraindications or known allergies to Enstilar® or its ingredients Incapacitated patients under institutionalized care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enstilar®<br>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. | Drug: Enstilar®<br>* Once daily application of cutaneous foam to plaques on body and/or extremities<br>* Other names: calcipotriol/betamethasone dipropionate cutaneous foam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment | 5-point Likert scale | 4 weeks | 
| PASI 50 | Psoriasis Area and Severity Index | 4 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis vulgaris, Plaque, Topical, Calcipotriol, Foam, Spray