Efficacy and Tolerability of Enstilar® in Daily Practice

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881346
• Other study ID #: NIS-ENSTILAR-1295
• Status: Completed
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Enstilar®
Once daily application of cutaneous foam to plaques on body and/or extremities

Locations

Country	Name	City	State
Germany	Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

Gerdes S, Krakor M, Anger T, Hutt HJ, Körber A. Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients with Plaque Psoriasis under Daily P — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Global Assessment	5-point Likert scale	Week 4
Primary	Percentage of total body surface area affected	Percentage	4 weeks
Primary	Absence of related adverse events (ADR)	Proportion of patients with no ADRs	4 weeks
Secondary	Patient Global Assessment	5-point Likert scale	4 weeks
Secondary	PASI 50	Psoriasis Area and Severity Index	4 weeks
Secondary	PASI 75	Psoriasis Area and Severity Index	4 weeks
Secondary	Patient reported itching	10-point scale	4 weeks
Secondary	Patient reported sleep loss	10-point scale	4 weeks
Secondary	Patient reported erythema	10-point scale	4 weeks
Secondary	Patient reported scaling	10-point scale	4 weeks
Secondary	Patient reported dry skin	10-point scale	4 weeks
Secondary	Patient reported overall treatment satisfaction	4-point Likert scale	4 weeks
Secondary	Patient reported satisfaction with effectiveness	4-point Likert scale	4 weeks
Secondary	Patient reported satisfaction with tolerability	4-point Likert scale	4 weeks
Secondary	Patient reported satisfaction with convenience	4-point Likert scale	4 weeks
Secondary	Dermatology Life Quality Index	Standard Quality of Life Questionnaire (DLQI)	4 weeks

External Links

•   Link to result publication