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

NCT02636101 | Completed

• 1 other identifier: NIS-DAIVOBETGEL-1210
• Study Type: observational
• Target: 603
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

• Patient reported treatment satisfaction

  Patient preference compared with previous therapy

  Around 8 weeks after treatment initiation

• Adherence to treatment

  Number of days during the last 7 days with no treatment

  Around 8 weeks after treatment initiation

Secondary Outcomes (5)

• Physician Global Assessment of Psoriasis

  Around 8 weeks after treatment initiation

• Frequency of treatment after completion of initial treatment

  12 months

• To evaluate the effect of treatment with Xamiol®gel on patients quality of life

  Around 8 weeks

• Overall rate of treatment success

  Around 8 weeks

• Patient's willingness to pay

  12 months

Interventions

Calcipotriol/betamethasone dipropionate gel DRUG

Topical treatment of psoriasis plaques located on the body

Also known as: Xamiol®, Daivobet®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with body psoriasis who (at their physician's discretion) are eligible to receive topical treatment with calcipotriol/betamethasone gel

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Municipal out-patient clinic 7

Saratov, 410012, Russia

Location

Related Publications (2)

• 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

  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).

  RESULT

Related Links

• Results

MeSH Terms

Interventions

calcipotriene; betamethasone dipropionate, calcipotriol drug combination

Study Officials

• Dmitry Petrunin, MD, PhD

  LEO Pharmaceutical Products LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 21, 2015
• Study Start: January 1, 2016
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: December 13, 2019

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)