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

Psoriasis Vulgaris Clinical Trial

— BODYGUARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636101
• Other study ID #: NIS-DAIVOBETGEL-1210
• Status: Completed
• Start date: January 2016
• Est. completion date: February 15, 2018

Study information

• Verified date: March 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Calcipotriol/betamethasone dipropionate gel
Topical treatment of psoriasis plaques located on the body

Locations

Country	Name	City	State
Russian Federation	Municipal out-patient clinic 7	Saratov

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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).

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported treatment satisfaction	Patient preference compared with previous therapy	Around 8 weeks after treatment initiation
Primary	Adherence to treatment	Number of days during the last 7 days with no treatment	Around 8 weeks after treatment initiation
Secondary	Physician Global Assessment of Psoriasis		Around 8 weeks after treatment initiation
Secondary	Frequency of treatment after completion of initial treatment		12 months
Secondary	To evaluate the effect of treatment with Xamiol®gel on patients quality of life	Dermatology Life Quality Index (DLQI)	Around 8 weeks
Secondary	Overall rate of treatment success	Clear or almost clear by Physician Psoriasis Global Assessment	Around 8 weeks
Secondary	Patient's willingness to pay	Total consumption during study period in Russia where Xamiol®gel is not reimbursed	12 months

External Links

•   Results