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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02636101

Acronym

BODYGUARD

Enrollment

603

Registered

2015-12-21

Start date

2016-01-31

Completion date

2018-02-15

Last updated

2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris

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.

Interventions

DRUGCalcipotriol/betamethasone dipropionate gel

Topical treatment of psoriasis plaques located on the body

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Patient reported treatment satisfaction	Around 8 weeks after treatment initiation	Patient preference compared with previous therapy
Adherence to treatment	Around 8 weeks after treatment initiation	Number of days during the last 7 days with no treatment

Secondary

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026