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

Xamiol® Gel in BODY Psoriasis : lonG-term Management of Psoriasis vUlgARis With Xamiol® Gel in Daily Clinical Practice of Russian Dermatologists. A Long-term Observational, Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Calcipotriol/betamethasone dipropionate gel

• Study Type: Observational
• Enrollment (Actual): 603

Contacts and Locations

Study Locations

• Russian Federation
  • Saratov, Russian Federation, 410012
    • Municipal out-patient clinic 7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Dermatology Life Quality Index (DLQI)	Around 8 weeks
Overall rate of treatment success	Clear or almost clear by Physician Psoriasis Global Assessment	Around 8 weeks
Patient's willingness to pay	Total consumption during study period in Russia where Xamiol®gel is not reimbursed	12 months

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Dmitry Petrunin, MD, PhD, Leo Pharmaceutical Products LLC

Publications and helpful links

General Publications

• 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
• 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).

Helpful Links

• Results

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): February 15, 2018

Study Registration Dates

• First Submitted: December 9, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
• Other Study ID Numbers: NIS-DAIVOBETGEL-1210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO