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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02881346
Other study ID # NIS-ENSTILAR-1295
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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