Plaque Psoriasis
Conditions
Keywords
Psoriasis vulgaris, Plaque, Topical, Calcipotriol, Foam, Spray
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,
Interventions
DRUGEnstilar®
Once daily application of cutaneous foam to plaques on body and/or extremities
Sponsors
LEO Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Global Assessment | 4 weeks | 5-point Likert scale |
| Patient reported satisfaction with effectiveness | 4 weeks | 4-point Likert scale |
| Patient reported satisfaction with tolerability | 4 weeks | 4-point Likert scale |
| Patient reported satisfaction with convenience | 4 weeks | 4-point Likert scale |
| Dermatology Life Quality Index | 4 weeks | Standard Quality of Life Questionnaire (DLQI) |
| Patient reported overall treatment satisfaction | 4 weeks | 4-point Likert scale |
| PASI 50 | 4 weeks | Psoriasis Area and Severity Index |
| PASI 75 | 4 weeks | Psoriasis Area and Severity Index |
Countries
Germany
Outcome results
None listed