Efficacy and Tolerability of Enstilar® in Daily Practice
- Registration Number
- NCT02881346
- Lead Sponsor
- LEO Pharma
- Brief Summary
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,
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 410
- ≥ 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Enstilar® 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.
- Primary Outcome Measures
Name Time Method Investigator Global Assessment Week 4 5-point Likert scale
Percentage of total body surface area affected 4 weeks Percentage
Absence of related adverse events (ADR) 4 weeks Proportion of patients with no ADRs
- Secondary Outcome Measures
Name Time Method Patient reported itching 4 weeks 10-point scale
Patient reported sleep loss 4 weeks 10-point scale
Patient reported erythema 4 weeks 10-point scale
Patient reported scaling 4 weeks 10-point scale
Patient reported dry skin 4 weeks 10-point scale
Patient reported overall treatment satisfaction 4 weeks 4-point Likert scale
PASI 50 4 weeks Psoriasis Area and Severity Index
Patient Global Assessment 4 weeks 5-point Likert scale
PASI 75 4 weeks Psoriasis Area and Severity Index
Patient reported satisfaction with tolerability 4 weeks 4-point Likert scale
Patient reported satisfaction with convenience 4 weeks 4-point Likert scale
Patient reported satisfaction with effectiveness 4 weeks 4-point Likert scale
Dermatology Life Quality Index 4 weeks Standard Quality of Life Questionnaire (DLQI)
Trial Locations
- Locations (1)
Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein
🇩🇪Kiel, Germany