Clinical trial NCT02881346: Efficacy and Tolerability of Enstilar® in Daily Practice
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Psoriasis vulgaris
Plaque
Topical
Calcipotriol
Foam
Spray
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2016-08-29
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with psoriasis vulgaris plaques on trunk and/or extremities of at least mild severity for whom topical treatment with Enstilar® is planned

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,


Eligibility criteria: 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

Primary outcomes:
measure: Investigator Global Assessment
timeFrame: Week 4
measure: Percentage of total body surface area affected
timeFrame: 4 weeks
measure: Absence of related adverse events (ADR)
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient Global Assessment
timeFrame: 4 weeks
measure: PASI 50
timeFrame: 4 weeks
measure: PASI 75
timeFrame: 4 weeks
measure: Patient reported itching
timeFrame: 4 weeks
measure: Patient reported sleep loss
timeFrame: 4 weeks
measure: Patient reported erythema
timeFrame: 4 weeks
measure: Patient reported scaling
timeFrame: 4 weeks
measure: Patient reported dry skin
timeFrame: 4 weeks
measure: Patient reported overall treatment satisfaction
timeFrame: 4 weeks
measure: Patient reported satisfaction with effectiveness
timeFrame: 4 weeks
measure: Patient reported satisfaction with tolerability
timeFrame: 4 weeks
measure: Patient reported satisfaction with convenience
timeFrame: 4 weeks
measure: Dermatology Life Quality Index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein
Study officials:
affiliation: Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein, Campus Kiel
name: Sascha Gerdes, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.