NCT02881346

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,

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

August 23, 2016

Last Update Submit

December 12, 2019

Conditions

Plaque Psoriasis

Keywords

Psoriasis vulgarisPlaqueTopicalCalcipotriolFoamSpray

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (13)

  • Patient Global Assessment

    4 weeks

  • PASI 50

    4 weeks

  • PASI 75

    4 weeks

  • Patient reported itching

    4 weeks

  • Patient reported sleep loss

    4 weeks

  • +8 more secondary outcomes

Study Arms (1)

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®

Interventions

Enstilar®DRUG

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

Also known as: calcipotriol/betamethasone dipropionate cutaneous foam
Enstilar®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kiel, Germany

Location

Related Publications (3)

  • 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.

    PMID: 24354461BACKGROUND

  • 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.

    PMID: 8033378BACKGROUND

  • 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.

    PMID: 29502110RESULT

Related Links

MeSH Terms

Conditions

Plaque, Amyloid

Interventions

betamethasone dipropionate, calcipotriol drug combinationcalcipotriene

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Sascha Gerdes, Dr.med.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 29, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

December 13, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)