Psoriasis of ScalpPhase 3NCT00243464
Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis
A Phase 3 study testing Calcipotriol plus betamethasone dipropionate (LEO80185 gel) in people with Psoriasis of Scalp, run by LEO Pharma at 5 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis of Scalp
- What is being tested?
- Calcipotriol plus betamethasone dipropionate (LEO80185 gel)
- How many people
- 300 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Sep 2005to May 2006
- Phase
- Phase 3
- 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
Main Inclusion Criteria:
- Scalp psoriasis amenable to topical treatment
- Psoriasis vulgaris on trunk and/or limbs
- Extent of scalp psoriasis involving more than 10% of the total scalp area
- Disease severity on the scalp graded as moderate or worse by the investigator
- Consenting out-patients of 18 years or above
Main Exclusion Criteria:
- PUVA or Grenz ray therapy within 4 weeks prior to randomisation
- UVB therapy within 2 weeks prior to randomisation
- Systemic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation
- Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
- Any topical treatment of the scalp (except for non steroid medicated shampoos and emollients) within 2 weeks prior to randomisation
- Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
- Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Belgium1 site
Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie
Leuven, 3000
About this study
Official title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.
Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.
- Conditions
- Psoriasis of Scalp
- Being tested
- Calcipotriol plus betamethasone dipropionate (LEO80185 gel)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol plus betamethasone dipropionate (LEO80185 gel)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall disease severity according to investigator's assessment at week 8
Secondary outcomes (5)
Total sign score at week 8
Score for redness, thickness and scaliness at week 8
Overall disease severity according to the investigator's assessment at week 2 and 4
Overall disease severity according to patients at week 8
Relapse and rebound during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startSep 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis of ScalpStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Knud Kragballe, MD, Principal investigator, Department of Dermatology, Marselisborg Centres
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243464
- Sponsor's protocol ID
- MBL 0503 INT
- Status last verified
- Mar 2015
- First submitted
- 21 Oct 2005
- Last updated
- 24 Feb 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT00243464
- Acronym / sponsor ID
- MBL 0503 INT
- Conditions
- Psoriasis of Scalp
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- May 2006
- First posted
- 24 Oct 2005 (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 study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.
Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 plus betamethasone dipropionate (LEO80185 gel) | Drug | – |
Primary outcome
Overall disease severity according to investigator's assessment at week 8
5 secondary outcomes
Total sign score at week 8
Score for redness, thickness and scaliness at week 8
Overall disease severity according to the investigator's assessment at week 2 and 4
Overall disease severity according to patients at week 8
Relapse and rebound during the study
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 24 Feb 2025.
- Clinical Trials at LEO PharmaLink 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.
Knud Kragballe, MD principal investigator
Department of Dermatology, Marselisborg Centres
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcipotriol plus betamethasone dipropionate (LEO80185 gel) in people with Psoriasis of Scalp, run by LEO Pharma at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Canada, Denmark, France, Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall disease severity according to investigator's assessment at week 8. 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 Feb 2025.