Xamiol®Gel in BODY Psoriasis: A One-year Non-interventional Study

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

603 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-02-15

Brief Summary

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This study aims to describe the patient population treated and the real-life patients' experiences with Xamiol®gel in the long term, up to 52 weeks management of body psoriasis vulgaris in Russia. The result will increase the knowledge on Xamiol®gel enabling dermatologists and patients to optimize its use in the long term management of psoriasis.

Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Calcipotriol/betamethasone dipropionate gel

Topical treatment of psoriasis plaques located on the body

Intervention Type DRUG

Other Intervention Names

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Xamiol® Daivobet®

Eligibility Criteria

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Inclusion Criteria

* Psoriasis vulgaris on body
* Patients planned to receive topical treatment on the body with calcipotriol/betamethasone gel
* Written informed consent

Exclusion Criteria

* No or very mild symptoms of psoriasis vulgaris on the body at study start
* Any on-going treatments at study start with topical steroids, salicylic acid or its combination
* Other topical treatment for body psoriasis
* Pregnancy or planned pregnancy within treatment period
* Contraindications according to prescribing information.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dmitry Petrunin, MD, PhD

Role: STUDY_DIRECTOR

LEO Pharmaceutical Products LLC

Locations

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Municipal out-patient clinic 7

Saratov, , Russia

Site Status

Countries

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Russia

References

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Results of the long-term observational noninterventional prospective study BODYGUARD in psoriasis patients Bakulev, A. L. [2] , and Petrunin, D. D. [1] , Vestnik dermatologii i venerologii (volume 95, issue 4, pages 87-93) , 10/19/2019

Reference Type RESULT

EADV 2019 Abstract P1788. Bakulev AL, Petrunin DD. Results from a long-term, observational, non-interventional, prospective study in patients with body psoriasis based on patient-reported outcomes and physician's assessments (BODYGUARD).