Psoriasis VulgarisNCT01707368
Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation
An observational study of Psoriasis Vulgaris and Plaque Psoriasis, run by LEO Pharma at 1 site in Germany.
Trial summary
The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris, Plaque Psoriasis
- What is being tested?
- Daivobet® Gel
- How many people
- 561 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Jul 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with Psoriasis vulgaris visiting their attending dermatologist in the primary care clinic
Who may be able to join
- Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway.
- Minimum of 3 years diagnosed psoriasis vulgaris.
Who cannot join
- Previous therapy with Daivobet® Gel
- Systemic therapy of psoriasis vulgaris
- Contraindications of Daivobet® Gel in the German package insert
- people that are incapable to give free consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Course of Psoriasis During Long Term Treatment With Calcipotriol Plus Betamethasone in Gel Formulation
The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions.
- Conditions
- Psoriasis Vulgaris, Plaque Psoriasis
- Being tested
- Daivobet® Gel
- Keywords
- Psoriasis, Psoriasis vulgaris, Plaque Psoriasis, Daivobet® Gel, Germany
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daivobet® GelDrug
Once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
| Study group | Role | What they receive |
|---|---|---|
| all eligible patients | Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance. Receives: Drug: Daivobet® Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.
Number of exacerbations and relapses during one year observation time
Measured: 1 year
Secondary outcomes (3)
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
6--point verbal rating scale
Measured: Baseline
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5)
Measured: 1 year
Side Effects
Number of participants with serious and non-serious adverse drug reactions.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Rosenberg, PD Dr. med., Principal investigator, private practise, D- 49078 Osnabrück, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707368
- Sponsor's protocol ID
- DE-Daivobet-longterm-NIS-2012
- Status last verified
- Jan 2018
- First submitted
- 12 Oct 2012
- Last updated
- 24 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Course of Psoriasis During Long Term Treatment With Calcipotriol Plus Betamethasone in Gel Formulation
- ClinicalTrials.gov ID
- NCT01707368
- Acronym / sponsor ID
- DE-Daivobet-longterm-NIS-2012
- Conditions
- Psoriasis Vulgaris, Plaque Psoriasis
- Keywords
- Psoriasis, Psoriasis vulgaris, Plaque Psoriasis, Daivobet® Gel, Germany
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Posted 24 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all eligible patients | – | Drug: Daivobet® GelDaivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Psoriasis vulgaris visiting their attending dermatologist in the primary care clinic
Key inclusion criteria (2 listed)
- Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway.
- Minimum of 3 years diagnosed psoriasis vulgaris.
Key exclusion criteria (4 listed)
- Previous therapy with Daivobet® Gel
- Systemic therapy of psoriasis vulgaris
- Contraindications of Daivobet® Gel in the German package insert
- people that are incapable to give free consent
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 |
|---|---|---|
| Daivobet® GelOnce daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance. | Drug | all eligible patients |
Primary outcome
The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.
Time frame: 1 year
Number of exacerbations and relapses during one year observation time
3 secondary outcomes
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Time frame: Baseline
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Time frame: 1 year
Side Effects
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas Rosenberg, PD Dr. med. principal investigator
private practise, D- 49078 Osnabrück, Germany
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 and Plaque Psoriasis, run by LEO Pharma at 1 site in Germany.
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 2 inclusion and 4 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 24 Sep 2018. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2018.