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OpenTrials
Completed

NCT Number: NCT02636101

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

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Municipal out-patient clinic 7

Saratov, 410012, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcipotriol/betamethasone dipropionate gel

Drug

Topical treatment of psoriasis plaques located on the body

Other names: Xamiol®, Daivobet®

Primary outcomes

  1. Patient reported treatment satisfaction

    Time frame: Around 8 weeks after treatment initiation

    Patient preference compared with previous therapy

  2. Adherence to treatment

    Time frame: Around 8 weeks after treatment initiation

    Number of days during the last 7 days with no treatment

Secondary outcomes

  1. Physician Global Assessment of Psoriasis

    Time frame: Around 8 weeks after treatment initiation

  2. Frequency of treatment after completion of initial treatment

    Time frame: 12 months

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

    Time frame: Around 8 weeks

    Dermatology Life Quality Index (DLQI)

  4. Overall rate of treatment success

    Time frame: Around 8 weeks

    Clear or almost clear by Physician Psoriasis Global Assessment

  5. Patient's willingness to pay

    Time frame: 12 months

    Total consumption during study period in Russia where Xamiol®gel is not reimbursed

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Acronym: BODYGUARD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2015
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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