Psoriasis VulgarisNCT01320774
Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris
An observational study of Psoriasis Vulgaris, run by LEO Pharma at 1 site in Germany.
Trial summary
The purpose of this observational study is to evaluate the efficacy, tolerability, quality of life and handling of Daivobet® Gel by both physician and patient in daily practise. 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?
- Daivobet® Gel
- How many people
- 588 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Jan 2012
- 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 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
Who cannot join
- Previous therapy with Daivobet® Gel
- Systemic therapy of psoriasis vulgaris
- Contraindications of Daivobet® Gel in the German package insert
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this observational study is to evaluate the efficacy, tolerability, quality of life and handling of Daivobet® Gel by both physician and patient in daily practise.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Daivobet® Gel
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Handling of Daivobet® Gel
Compared to previous topical treatment: Time required for application (previous treatment versus present treatment), time required until dressing is possible (previous treatment versus present treatment)
Measured: After appr 4 weeks
Secondary outcomes (3)
Quality of life
Dermatology Life Quality Index (DLQI)
Measured: 4 weeks
Physician's global Assessment of psoriasis vulgaris
6-step scale from "no visible disease (O)" to "very severe disease (5)
Measured: 4 weeks
Side effects
number of participants with serious and non-serious adverse drug reactions, according to organ classes
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LEO Pharma GmbH, Neu-Isenburg, Germany
- Responsible party
- Sponsor
- Investigators
- Michael Sticherling, Prof dr med, Principal investigator, University clinic Erlangen-Nuernberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320774
- Sponsor's protocol ID
- Treatment with Daivobet® Gel
- Status last verified
- Feb 2012
- First submitted
- 18 Mar 2011
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01320774
- Acronym / sponsor ID
- Treatment with Daivobet® Gel
- Conditions
- Psoriasis Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- LEO Pharma GmbH, Neu-Isenburg, Germany
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Mar 2011 (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.
The purpose of this observational study is to evaluate the efficacy, tolerability, quality of life and handling of Daivobet® Gel by both physician and patient in daily practise.
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 visiting their attending dermatologist in the primary care clinic
Key inclusion criteria (1 listed)
- Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway
Key exclusion criteria (3 listed)
- Previous therapy with Daivobet® Gel
- Systemic therapy of psoriasis vulgaris
- Contraindications of Daivobet® Gel in the German package insert
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 | – |
Primary outcome
Handling of Daivobet® Gel
Time frame: After appr 4 weeks
Compared to previous topical treatment: Time required for application (previous treatment versus present treatment), time required until dressing is possible (previous treatment versus present treatment)
3 secondary outcomes
Quality of life
Time frame: 4 weeks
Physician's global Assessment of psoriasis vulgaris
Time frame: 4 weeks
Side effects
Time frame: 4 weeks
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 10 Feb 2012.
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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.
Michael Sticherling, Prof dr med principal investigator
University clinic Erlangen-Nuernberg
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 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 1 inclusion and 3 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 10 Feb 2012. 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?
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?
Handling of Daivobet® Gel (time frame: After appr 4 weeks). 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 10 Feb 2012.