Psoriasis VulgarisPhase 3NCT00640822
Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds
A Phase 3 study testing Tacalcitol Ointment and Calcipotriol plus hydrocortisone ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 3 sites in 3 countries.
Trial summary
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. 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?
- Tacalcitol Ointment and Calcipotriol plus hydrocortisone ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 782 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2008to Jul 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
- Clinical diagnosis of psoriasis vulgaris involving the face
- Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
- An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
- Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 10 g of ointment per day
- Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face
Who cannot join
- Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
- Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
- PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
- UVB therapy within the 2-week period prior to randomisation
- Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the study)
- Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
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- Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
- Systemic treatment with vitamin D preparations above 500 IU per day
- Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
- Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
- Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the face or on the intertriginous areas
- Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study
- Known or suspected severe renal insufficiency or severe hepatic disorders
- Known or suspected disorders of calcium metabolism associated with hypercalcemia
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Ninewells Hospital & Medical School
Dundee, DD1 9SY
About this study
Official title: A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intertriginous Areas
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares
- Conditions
- Psoriasis Vulgaris
- Being tested
- Calcipotriol plus hydrocortisone ointment vehicle, Tacalcitol Ointment, Calcipotriol plus hydrocortisone ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol plus hydrocortisone ointment vehicleDrug
Once daily application for up to 8 weeks
Tacalcitol OintmentDrug
Once daily application for up to 8 weeks
Calcipotriol plus hydrocortisone ointmentDrug
Once daily application for up to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriol plus Hydrocortisone ointment | Experimental | Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks Receives: Drug: Calcipotriol plus hydrocortisone ointment |
| Tacalcitol | Active comparator | Tacalcitol once daily for up to 8 weeks Receives: Drug: Tacalcitol Ointment |
| Calcipotriol plus Hydrocortisone ointment vehicle | Placebo comparator | Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks Receives: Drug: Calcipotriol plus hydrocortisone ointment vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8
Measured: Week 8
Secondary outcomes (7)
Overall Disease Severity of the Face According to the Investigator's Assessment
Measured: Week 4
Total Sign Score of the Face
Measured: Week 8
Severity Scores for Redness, Thickness and Scaliness of the Face
Measured: Week 8
Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment
Measured: Week 8
Total Sign Score of the Intertriginous Areas
Measured: Week 8
Patients With Relapse During the Study and Time to Relapse
Measured: Week 8-16
Patients 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 posted21 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
- Study completionJul 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
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Fleming, MD, Principal investigator, Ninewells Hospital & Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640822
- Sponsor's protocol ID
- LEO 80190-O22
- Status last verified
- Apr 2015
- First submitted
- 18 Mar 2008
- Last updated
- 7 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intertriginous Areas
- ClinicalTrials.gov ID
- NCT00640822
- Acronym / sponsor ID
- LEO 80190-O22
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 782 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Posted 21 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcipotriol plus Hydrocortisone ointment | Experimental | Drug: Calcipotriol plus hydrocortisone ointmentCalcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks |
| Tacalcitol | Active comparator | Drug: Tacalcitol OintmentTacalcitol once daily for up to 8 weeks |
| Calcipotriol plus Hydrocortisone ointment vehicle | Placebo comparator | Drug: Calcipotriol plus hydrocortisone ointment vehicleCalcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of psoriasis vulgaris involving the face
- Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
- An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
- Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 10 g of ointment per day
- Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face
Key exclusion criteria (14 listed)
- Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
- Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
- PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
- UVB therapy within the 2-week period prior to randomisation
- Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the study)
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 hydrocortisone ointment vehicleOnce daily application for up to 8 weeks | Drug | Calcipotriol plus Hydrocortisone ointment vehicle |
| Tacalcitol OintmentOnce daily application for up to 8 weeks | Drug | Tacalcitol |
| Calcipotriol plus hydrocortisone ointmentOnce daily application for up to 8 weeks | Drug | Calcipotriol plus Hydrocortisone ointment |
Primary outcome
Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8
Time frame: Week 8
7 secondary outcomes
Overall Disease Severity of the Face According to the Investigator's Assessment
Time frame: Week 4
Total Sign Score of the Face
Time frame: Week 8
Severity Scores for Redness, Thickness and Scaliness of the Face
Time frame: Week 8
Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment
Time frame: Week 8
Total Sign Score of the Intertriginous Areas
Time frame: Week 8
Patients With Relapse During the Study and Time to Relapse
Time frame: Week 8-16
Patients 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 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Colin Fleming, MD principal investigator
Ninewells Hospital & Medical School
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacalcitol Ointment and Calcipotriol plus hydrocortisone ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 3 sites in 3 countries.
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 5 inclusion and 14 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 7 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 3 sites in Canada, France, United Kingdom. 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 21 Dec 2010). 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 According to the Investigator Assessment of the Face 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 7 Mar 2025.