Psoriasis VulgarisBODYGUARDNCT02636101
Xamiol®Gel in BODY Psoriasis: A One-year Non-interventional Study
An observational study of Psoriasis Vulgaris, run by LEO Pharma at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Calcipotriol/betamethasone dipropionate gel
- How many people
- 603 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2016to 15 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with body psoriasis who (at their physician's discretion) are eligible to receive topical treatment with calcipotriol/betamethasone gel
Who may be able to join
- Psoriasis vulgaris on body
- Patients planned to receive topical treatment on the body with calcipotriol/betamethasone gel
- Written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Calcipotriol/betamethasone dipropionate gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol/betamethasone dipropionate gelDrug
Also called Xamiol®, Daivobet®
Topical treatment of psoriasis plaques located on the body
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported treatment satisfaction
Patient preference compared with previous therapy
Measured: Around 8 weeks after treatment initiation
Adherence to treatment
Number of days during the last 7 days with no treatment
Measured: Around 8 weeks after treatment initiation
Secondary outcomes (5)
Physician Global Assessment of Psoriasis
Measured: Around 8 weeks after treatment initiation
Frequency of treatment after completion of initial treatment
Measured: 12 months
To evaluate the effect of treatment with Xamiol®gel on patients quality of life
Dermatology Life Quality Index (DLQI)
Measured: Around 8 weeks
Overall rate of treatment success
Clear or almost clear by Physician Psoriasis Global Assessment
Measured: Around 8 weeks
Patient's willingness to pay
Total consumption during study period in Russia where Xamiol®gel is not reimbursed
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dmitry Petrunin, MD, PhD, Study director, LEO Pharmaceutical Products LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636101
- Sponsor's protocol ID
- NIS-DAIVOBETGEL-1210
- Acronym
- BODYGUARD
- Status last verified
- Mar 2017
- First submitted
- 9 Dec 2015
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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).
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02636101
- Acronym / sponsor ID
- BODYGUARD / NIS-DAIVOBETGEL-1210
- Conditions
- Psoriasis Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with body psoriasis who (at their physician's discretion) are eligible to receive topical treatment with calcipotriol/betamethasone gel
Key inclusion criteria (3 listed)
- Psoriasis vulgaris on body
- Patients planned to receive topical treatment on the body with calcipotriol/betamethasone gel
- Written informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcipotriol/betamethasone dipropionate gelAlso: Xamiol®, Daivobet®Topical treatment of psoriasis plaques located on the body | Drug | – |
Primary outcome
Patient reported treatment satisfaction
Time frame: Around 8 weeks after treatment initiation
Patient preference compared with previous therapy
Adherence to treatment
Time frame: Around 8 weeks after treatment initiation
Number of days during the last 7 days with no treatment
5 secondary outcomes
Physician Global Assessment of Psoriasis
Time frame: Around 8 weeks after treatment initiation
Frequency of treatment after completion of initial treatment
Time frame: 12 months
To evaluate the effect of treatment with Xamiol®gel on patients quality of life
Time frame: Around 8 weeks
Overall rate of treatment success
Time frame: Around 8 weeks
Patient's willingness to pay
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Results publicationResults 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
- Results publicationEADV 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).
- ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitry Petrunin, MD, PhD study director
LEO Pharmaceutical Products LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris, run by LEO Pharma at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported treatment satisfaction (time frame: Around 8 weeks after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02636101, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.