Psoriasis VulgarisPhase 3NCT00670241
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris
A Phase 3 study testing calcipotriol and betamethasone (LEO 80185 gel) and Tacalcitol ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Canada.
Trial summary
This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. 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 and betamethasone (LEO 80185 gel) and Tacalcitol ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 458 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Apr 2009
- Phase
- Phase 3
- 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
Who may be able to join
- Signed and dated informed consent to be obtained prior to any trial related procedure, including wash-out
- Clinical diagnosis of psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of LEO 80185 gel per week or 10 g per day of tacalcitol ointment
- Disease severity graded moderate, severe or very severe according to the Investigator's global assessment (IGA) of disease severity
- A minimum PASI score for extent of 2 in at least one body region (i.e.psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)
- Subjects aged 18 years or above
- Either sex
- Any ethnic origin
- Attending hospital outpatient clinic or the private practice of a dermatologist
Who cannot join
- Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
- Systemic treatment with all other therapies than biologics, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 4 weeks prior to randomisation
- Systemic treatment with Vitamin D preparations above 500 IU per day
- PUVA or Grenz ray therapy within 4 weeks prior to randomization
- UVB therapy within 2 weeks prior to randomisation
- Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation
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- Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with potent or very potent (WHO group III-IV) corticosteroids or vitamin D analogues within 2 weeks prior to randomisation
- Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with very potent (WHO group IV) corticosteroids or vitamin D analogues within 2 weeks prior to randomisation
- Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) during the study
- Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
- Subjects with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atro-phicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia
- Known or suspected severe renal insufficiency or severe hepatic disorders
- Known or suspected hypersensitivity to component(s) of the Investigational Products
- Current participation in any other interventional clinical study
- Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation, except for biologics (3 months)
- Planned exposure to sun during the study that may affect psoriasis vulgaris
- Previously randomised to this study
- Subjects known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychotic state)
- Females of child-bearing potential wishing to become pregnant during the study, or are breast-feeding, or not using an adequate method of contraception during the study
- Females of child-bearing potential with positive pregnancy test at Visit 1
Trial locations and contacts
1 site in 1 country.
Canada1 site
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, B3H 1Z4
About this study
Official title: A Phase 3 Study Comparing a Gel Containing Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) With Tacalcitol Ointment (4 mcg/g) and Gel Vehicle, Used Once Daily in the Treatment of Psoriasis Vulgaris
This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to investigate the occurence and the time to relapse and occurence of rebound after discontinuation of the investigational products. Only subjects with "controlled disease" will be considered for this observation phase of the study. "Controlled disease" is defined as "Clear" or "Almost Clear" severity category based on Investigator's global assessment (IGA).
- Conditions
- Psoriasis Vulgaris
- Being tested
- calcipotriol and betamethasone (LEO 80185 gel), LEO 80185 vehicle, Tacalcitol ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcipotriol and betamethasone (LEO 80185 gel)Drug
Once daily application
LEO 80185 vehicleDrug
Once daily application
Tacalcitol ointmentDrug
Once daily application
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: calcipotriol and betamethasone (LEO 80185 gel) |
| 2 | Active comparator | Not described Receives: Drug: Tacalcitol ointment |
| 3 | Placebo comparator | Not described Receives: Drug: LEO 80185 vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8
Measured: Week 8
Secondary outcomes (4)
Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity at Week 4
Measured: Week 4
The Percentage Change in PASI From Baseline to Week 8
PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst).
Measured: Baseline, Week 4 and 8
Subjects With Relapse During the Study
Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit
Measured: Week 8-16
Subjects With Rebound During the Study
Measured: Week 8-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2009
- Study completionApr 2009
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Langley, MD, Principal investigator, Eastern Canada Cutaneous Research Associates Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670241
- Sponsor's protocol ID
- LEO 80185-G21
- Status last verified
- Mar 2015
- First submitted
- 29 Apr 2008
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study Comparing a Gel Containing Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) With Tacalcitol Ointment (4 mcg/g) and Gel Vehicle, Used Once Daily in the Treatment of Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT00670241
- Acronym / sponsor ID
- LEO 80185-G21
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 1 May 2008 (estimated)
- Results
- Posted 8 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to investigate the occurence and the time to relapse and occurence of rebound after discontinuation of the investigational products. Only subjects with "controlled disease" will be considered for this observation phase of the study. "Controlled disease" is defined as "Clear" or "Almost Clear" severity category based on Investigator's global assessment (IGA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: calcipotriol and betamethasone (LEO 80185 gel) |
| 2 | Active comparator | Drug: Tacalcitol ointment |
| 3 | Placebo comparator | Drug: LEO 80185 vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed and dated informed consent to be obtained prior to any trial related procedure, including wash-out
- Clinical diagnosis of psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of LEO 80185 gel per week or 10 g per day of tacalcitol ointment
- Disease severity graded moderate, severe or very severe according to the Investigator's global assessment (IGA) of disease severity
- A minimum PASI score for extent of 2 in at least one body region (i.e.psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)
- Subjects aged 18 years or above
Key exclusion criteria (21 listed)
- Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
- Systemic treatment with all other therapies than biologics, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 4 weeks prior to randomisation
- Systemic treatment with Vitamin D preparations above 500 IU per day
- PUVA or Grenz ray therapy within 4 weeks prior to randomization
- UVB therapy within 2 weeks prior to randomisation
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 and betamethasone (LEO 80185 gel)Once daily application | Drug | 1 |
| LEO 80185 vehicleOnce daily application | Drug | 3 |
| Tacalcitol ointmentOnce daily application | Drug | 2 |
Primary outcome
Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8
Time frame: Week 8
4 secondary outcomes
Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity at Week 4
Time frame: Week 4
The Percentage Change in PASI From Baseline to Week 8
Time frame: Baseline, Week 4 and 8
Subjects With Relapse During the Study
Time frame: Week 8-16
Subjects With Rebound During the Study
Time frame: Week 8-16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Richard Langley, MD principal investigator
Eastern Canada Cutaneous Research Associates Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing calcipotriol and betamethasone (LEO 80185 gel) and Tacalcitol ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Canada.
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 8 inclusion and 21 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 Mar 2025. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 8 Mar 2011). 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?
Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8 (time frame: 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 10 Mar 2025.