PsoriasisPhase 3NCT01422434
LEO 90105 Ointment in Japanese Subjects With Psoriasis
A Phase 3 study testing LEO 90105 = calcipotriol + betamethasone dipropionate, Dovonex® = calcipotriol and Rinderon® - DP = betamethasone dipropionate in people with Psoriasis, run by LEO Pharma at 1 site in Japan.
Trial summary
The purpose of this study is to compare the efficacy of LEO 90105 ointment applied once daily with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once daily in Japanese subjects with psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- LEO 90105 = calcipotriol + betamethasone dipropionate, Dovonex® = calcipotriol and Rinderon® - DP = betamethasone dipropionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 676 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2011to Apr 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects having understood and signed a written informed consent form prior to any study related procedures being carried out.
- Japanese subjects.
- 20 years of age or above.
- Either sex.
- Clinical diagnosis of psoriasis vulgaris amenable to topical treatment, involving arms and/or trunk and/or legs.
- A minimum m-PASI (Modified Psoriasis Area and Severity Index) score for extent of 2 in at least one body region (i.e.
Show all 10Show fewer
- psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs).
- Psoriasis vulgaris on the trunk/limbs (excluding psoriasis on the genitals/skin folds) of not more than 30% body surface area (BSA).
- A target lesion of a minimum of 5 cm at its longest axis and preferably not located on an elbow or knee, scoring at least 3 for each of redness, thickness and scaliness, and at least 10 in total by the physician's assessment of severity of the target lesion - A physician's global assessment of disease severity of psoriasis on trunk/limbs of mild, moderate, severe or very severe.
- Females of childbearing potential must have a negative result for a urine pregnancy test at Day 0 (Visit 1) and must agree to use an adequate method of birth control, as judged by the (sub)investigator, during the study. The contraceptive method should have started an adequate amount of time before the pregnancy test, which is dependent on the partic-ular method used and as judged by the (sub)investigator, and must continue for at least 1 week after the last application of study medication. A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alter-native medical cause) or surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).
Who cannot join
- Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the following time periods prior to randomisation:
- etanercept, adalimumab, infliximab - 3 months
- ustekinumab - 4 months
- other products - 3 months/5 half-lives (whichever is longer).
- Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immu-nosuppressants such as ciclosporin and methotrexate) within 4 weeks prior to randomi-sation (use of inhaled and nasal corticosteroids is allowed, use of systemic antihistamines is allowed).
- Psoralen plus ultraviolet light A (PUVA) therapy, ultraviolet light B (UVB) therapy or ultraviolet light A (UVA) therapy within 4 weeks prior to randomisation.
Show all 25Show fewer
- Topical treatment of psoriasis on area(s) to be treated with study medication within 2 weeks prior to randomisation (use of emollients is allowed during this 2-week period, but not after randomisation).
- Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D ana-logues (e.g. calcipotriol, tacalcitol, maxacalcitol), or potent or very potent World Health Organisation (WHO) group III or IV corticosteroids within 2 weeks prior to randomisation.
- Topical treatment of scalp psoriasis with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or very potent WHO group IV corticosteroids within 2 weeks prior to randomisation.
- Topical treatment of conditions other than psoriasis with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or potent or very potent WHO group III or IV cor-ticosteroids within 2 weeks prior to randomisation.
- Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris (e.g., beta-blockers, antimalaria drugs, lithium and Angiotensin Converting Enzyme (ACE) inhibitors) during the study.
- Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis.
- Patients with any of the following disorders (a) or symptoms (b) present on the area(s) to be treated with study medication: (a) viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, atrophic skin, striae atrophicae, ichthyosis, acne rosacea, ulcers, burns, frostbite, wounds, or (b) fragility of skin veins..
- Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the trunk/limbs.
- Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc) during the study.
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia, or albumin-corrected serum calcium above the reference range from the sample taken at the Washout/Screening Visit.
- Known or suspected severe renal insufficiency, severe hepatic disorders or severe heart disease.
- Known or suspected hypersensitivity to any components of the investigational products.
- Clinical signs or symptoms of Cushing's disease or Addison's disease
- 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 weeks prior to randomisation, or longer if the class of substance requires a longer washout as defined in exclusion criterion number 1 for biological treatments.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Patients suspected of being unable to comply with the study protocol, e.g. due to alcoholism, drug dependence or psychotic state.
- Previous randomisation in this study.
- Hospitalised patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of LEO 90105 Ointment (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris
The purpose of this study is to compare the efficacy of LEO 90105 ointment applied once daily with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once daily in Japanese subjects with psoriasis vulgaris.
Read the detailed description
LEO 90105 ointment contains both calcipotriol and betamethasone dipropionate. It has been approved for the treatment of psoriasis in more than 60 centres, including most European countries, the US, China, Korea and Taiwan. This trial will investigate its safety and efficacy in the treatment of Japanese subjects with psoriasis.
- Conditions
- Psoriasis
- Being tested
- LEO 90105 = calcipotriol + betamethasone dipropionate, Dovonex® = calcipotriol, Rinderon® - DP = betamethasone dipropionate
- Keywords
- A national, multi-centre, prospective, randomised, double-blind, active-controlled, 3-arm, parallel group, 4 week study
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90105 = calcipotriol + betamethasone dipropionateDrug
Also called LEO 90105 = Dovobet/Daivobet/Taclonex
Applied once daily for 4 weeks.
Dovonex® = calcipotriolDrug
Applied twice daily for 4 weeks.
Rinderon® - DP = betamethasone dipropionateDrug
Applied once daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LEO 90105 ointment | Active comparator | LEO 90105 ointment applied once daily for 4 weeks. Receives: Drug: LEO 90105 = calcipotriol + betamethasone dipropionate |
| Dovonex® ointment | Active comparator | Applied twice daily for 4 weeks. Receives: Drug: Dovonex® = calcipotriol |
| Rinderon® - DP ointment | Active comparator | Applied once daily for 4 weeks Receives: Drug: Rinderon® - DP = betamethasone dipropionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)
The primary response criterion was the percentage change in m-PASI from baseline to Week 4.
The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI using the following formula:
Arms: 0.2(R+T+S)E = X Trunk: 0.2(R+T+S)E = Y Legs: 0.2(R+T+S)E = Z where R = score for redness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) T = score for thickness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) S = score for scaliness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) E = score for extent (using a scale from 0 to 6, where 0 is no involvement and 6 is 90-100% involvemnet) The sum of X + Y + Z gave the total m-PASI, which could range from 0 to 64.8.
Measured: Baseline to Week 4
Secondary outcomes (3)
Change From Baseline in Target Lesion Assessment
Percentage change in composite severity score of the target lesion from baseline to Week 4.
At Visit 1, the investigator selected a target lesion. Location was recorded as trunk, limb excluding elbow and/or knee.
At Visits 1-4, the investigator assessed the severity of the target lesion for each sign (redness, thickness and scaliness) on a scale from 0 to 8 where 0 is no signs of redness, thickness or scaliness and 8 is the most severe signs of redness, thickeness or scaliniess.
The individual scores for redness, thickness and scaliness were added together to give a single composite score for severity of the target lesion which could range from 0 to 24. The percentage change in the composite severity score from baseline to each visit was also calcutated.
Measured: Baseline to Week 4
Physician's Global Assessment of Psoriasis
Subjects with 'clear' or 'almost clear' disease by physician's global assessment on the following 6 point scale: clear, almost clear, mild, moderate, severe, very severe.
The assessment represents the average lesion severity on the trunk and limbs. The assessment was based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit.
Measured: Week 4
Change in mPASI From Baseline to Week 1
The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI. The m-PASI could range from 0 to 64.8. The least severe outcome is 0 and the most severe outcome is 64.8
Measured: Baseline to Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionApr 2012
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 PsoriasisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Akira Ozawa, MD, Professor, Principal investigator, Tokai University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422434
- Sponsor's protocol ID
- MCB 0903
- Status last verified
- Mar 2015
- First submitted
- 15 Aug 2011
- Last updated
- 12 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of LEO 90105 Ointment (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01422434
- Acronym / sponsor ID
- MCB 0903
- Conditions
- Psoriasis
- Keywords
- A national, multi-centre, prospective, randomised, double-blind, active-controlled, 3-arm, parallel group
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 Aug 2011 (estimated)
- Results
- Posted 11 Mar 2014
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 compare the efficacy of LEO 90105 ointment applied once daily with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once daily in Japanese subjects with psoriasis vulgaris.
Detailed description
LEO 90105 ointment contains both calcipotriol and betamethasone dipropionate. It has been approved for the treatment of psoriasis in more than 60 centres, including most European countries, the US, China, Korea and Taiwan. This trial will investigate its safety and efficacy in the treatment of Japanese subjects with psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LEO 90105 ointment | Active comparator | Drug: LEO 90105 = calcipotriol + betamethasone dipropionateLEO 90105 ointment applied once daily for 4 weeks. |
| Dovonex® ointment | Active comparator | Drug: Dovonex® = calcipotriolApplied twice daily for 4 weeks. |
| Rinderon® - DP ointment | Active comparator | Drug: Rinderon® - DP = betamethasone dipropionateApplied once daily for 4 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects having understood and signed a written informed consent form prior to any study related procedures being carried out.
- Japanese subjects.
- 20 years of age or above.
- Either sex.
- Clinical diagnosis of psoriasis vulgaris amenable to topical treatment, involving arms and/or trunk and/or legs.
Key exclusion criteria (25 listed)
- Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the following time periods prior to randomisation:
- etanercept, adalimumab, infliximab - 3 months
- ustekinumab - 4 months
- other products - 3 months/5 half-lives (whichever is longer).
- Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immu-nosuppressants such as ciclosporin and methotrexate) within 4 weeks prior to randomi-sation (use of inhaled and nasal corticosteroids is allowed, use of systemic antihistamines is allowed).
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 |
|---|---|---|
| LEO 90105 = calcipotriol + betamethasone dipropionateAlso: LEO 90105 = Dovobet/Daivobet/TaclonexApplied once daily for 4 weeks. | Drug | LEO 90105 ointment |
| Dovonex® = calcipotriolApplied twice daily for 4 weeks. | Drug | Dovonex® ointment |
| Rinderon® - DP = betamethasone dipropionateApplied once daily for 4 weeks. | Drug | Rinderon® - DP ointment |
Primary outcome
Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)
Time frame: Baseline to Week 4
The primary response criterion was the percentage change in m-PASI from baseline to Week 4. The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI using the following formula: Arms: 0.2(R+T+S)E = X Trunk: 0.2(R+T+S)E = Y Legs: 0.2(R+T+S)E = Z where R = score for redness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) T = score for thickness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) S = score for scaliness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) E = score for extent (using a scale from 0 to 6, where 0 is no involvement and 6 is 90-100% involvemnet) The sum of X + Y + Z gave the total m-PASI, which could range from 0 to 64.8.
3 secondary outcomes
Change From Baseline in Target Lesion Assessment
Time frame: Baseline to Week 4
Physician's Global Assessment of Psoriasis
Time frame: Week 4
Change in mPASI From Baseline to Week 1
Time frame: Baseline to Week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Akira Ozawa, MD, Professor principal investigator
Tokai University School of Medicine
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 LEO 90105 = calcipotriol + betamethasone dipropionate, Dovonex® = calcipotriol and Rinderon® - DP = betamethasone dipropionate in people with Psoriasis, run by LEO Pharma at 1 site in Japan.
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 10 inclusion and 25 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 12 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 Japan. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2014). 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?
Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI) (time frame: Baseline to Week 4). 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 12 Mar 2025.