Efficacy and Tolerability of Enstilar® in Daily Practice

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

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,

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Enstilar®

• Study Type: Observational
• Enrollment (Actual): 410

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany
    • Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Enstilar®; Once daily application of cutaneous foam to plaques on body and/or extremities; Other Names: calcipotriol/betamethasone dipropionate cutaneous foam

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Sascha Gerdes, Dr.med., Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein, Campus Kiel

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Link to result publication

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Topical; Plaque; Psoriasis vulgaris; Calcipotriol; Foam; Spray
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
• Other Study ID Numbers: NIS-ENSTILAR-1295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No