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Efficacy and Tolerability of Enstilar® in Daily Practice

NCT ID: NCT02881346

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Plaque Psoriasis

Keywords

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Psoriasis vulgaris Plaque Topical Calcipotriol Foam Spray

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Enstilar®

Intervention Type DRUG

Once daily application of cutaneous foam to plaques on body and/or extremities

Interventions

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Enstilar®

Once daily application of cutaneous foam to plaques on body and/or extremities

Intervention Type DRUG

Other Intervention Names

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calcipotriol/betamethasone dipropionate cutaneous foam

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sascha Gerdes, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein

Kiel, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 24354461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8033378 (View on PubMed)

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.

Reference Type RESULT
PMID: 29502110 (View on PubMed)

Other Identifiers

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NIS-ENSTILAR-1295

Identifier Type: -

Identifier Source: org_study_id