Psoriasis VulgarisPhase 1/2NCT01768013
The Pharmacokinetics of LEO 90105 (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Extensive Psoriasis Vulgaris
A Phase 1/2 study testing LEO 90105 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Japan.
Trial summary
The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 90105
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2012to Oct 2012
- Phase
- Phase 1/2
- 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
- Japanese subjects having understood and signed a written informed consent form prior to any study related procedures being carried out (including activities related to the wash out period)
- 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.
- Psoriasis vulgaris on the trunk/limbs (excluding psoriasis on the genitals/skin folds) of not more than 30% body surface area (BSA)
- An Investigator's global assessment of disease severity (IGA) on area(s) to be treated of moderate, severe or very severe and a m-PASI score of ≥12.
- Females of childbearing potential must have a negative result for a urine pregnancy test at Day 1 (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 particular 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 Visit 1:
- etanercept, adalimumab, infliximab -3 months.
- ustekinumab - 4 months
- other products - within 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 Visit 1 (use of inhaled and nasal corticosteroids is allowed, use of systemic antihistamines is allowed).
- 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 Visit 1.
Show all 25Show fewer
- PUVA therapy, UVB therapy or UVA therapy within 4 weeks prior to Visit 1.
- Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or potent or very potent WHO group III or IV corticosteroids within 2 weeks prior to Visit 1.
- Topical treatment of psoriasis on area(s) to be treated with study medication within the 2-week period prior to Visit 1. (Use of emollients is allowed during this 2- week period, but not during the study.)
- Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris (e.g., beta-blockers, antimalaria drugs, lithium and ACE inhibitors) during the study.
- 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 corti-costeroids within 2 weeks prior to Visit 1.
- Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis.
- Clinical signs or symptoms of Cushing's disease or Addison's disease
- 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.
- Planned excessive exposure of treated areas(s) to either natural or artificial sunlight (including tanning boths, sun lamps, etc) during the study.
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia (subjects with results for albumin-corrected serum calcium above the reference range from the sample taken at the Washout/Screening Visit.
- Severe renal insufficiency, severe hepatic disorders or severe heart disease.
- Known or suspected hypersensitivity to components 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 Visit 1 or longer, if the class of substance re-quires a longer washout as defined above (e.g. 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 enrollment in this study.
- Hospitalised patients.
Trial locations and contacts
1 site in 1 country.
About this study
The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 90105
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90105Drug
Once daily for four weeks
| Study group | Role | What they receive |
|---|---|---|
| LEO 90105 Ointment | Experimental | Not described Receives: Drug: LEO 90105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic: Cmax of Betamethasone Dipropionate
The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.
Measured: Day 1
Pharmacokinetic: Cmax of Betamethasone Dipropionate
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined
Measured: Day 7
Pharmacokinetic: Cmax of Betamethasone Dipropionate
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined
Measured: Day 14
Pharmacokinetic: AUClast of Betamethasone Dipropionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Measured: Day 1
Pharmacokinetic: AUClast of Betamethasone Dipropionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Measured: Day 7
Pharmacokinetic: AUClast of Betamethasone Dipropionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Measured: Day 14
Pharmacokinetic: Cmax of Betamethasone 17-propionate
The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Measured: Day 1
Pharmacokinetic: Cmax of Betamethasone 17-propionate
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Measured: Day 7
Pharmacokinetic: Cmax of Betamethasone 17-propionate
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Measured: Day 14
Pharmacokinetic: AUClast of Betamethasone 17-propionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Measured: Day 1
Pharmacokinetic: AUClast of Betamethasone 17-propionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Measured: Day 7
Pharmacokinetic: AUClast of Betamethasone 17-propionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Measured: Day 14
Pharmacokinetic: Cmax of Calcipotriol
The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Measured: Day 1
Pharmacokinetic: Cmax of Calcipotriol
The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Measured: Day 7
Pharmacokinetic: Cmax of Calcipotriol
The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Measured: Day 14
Pharmacokinetic: AUClast of Calcipotriol
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Measured: Day 1
Pharmacokinetic: AUClast of Calcipotriol
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Measured: Day 7
Pharmacokinetic: AUClast of Calcipotriol
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Measured: Day 14
Pharmacokinetic: Cmax of MC1080
The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Measured: Day 1
Pharmacokinetic: Cmax of MC1080
The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Measured: Day 7
Pharmacokinetic: Cmax of MC1080
The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Measured: Day 14
Pharmacokinetic: AUClast of MC1080
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Measured: Day 1
Pharmacokinetic: AUClast of MC1080.
To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Measured: Day 7
Pharmacokinetic: AUClast of MC1080.
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Measured: Day 14
Secondary outcomes (2)
Efficacy: Percentage Change in m-PASI From Baseline to Day 28
Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease.
The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified.
Measured: Baseline to Day 28
Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.
Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28.
Investigator global assessment (IGA) is based on the investigator's assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionOct 2012
- Study completionOct 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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768013
- Sponsor's protocol ID
- MCB 0904
- Status last verified
- May 2015
- First submitted
- 10 Jan 2013
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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
- The Pharmacokinetics of LEO 90105 (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Extensive Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01768013
- Acronym / sponsor ID
- MCB 0904
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Posted 30 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEO 90105 Ointment | Experimental | Drug: LEO 90105 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Japanese subjects having understood and signed a written informed consent form prior to any study related procedures being carried out (including activities related to the wash out period)
- 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.
- Psoriasis vulgaris on the trunk/limbs (excluding psoriasis on the genitals/skin folds) of not more than 30% body surface area (BSA)
Key exclusion criteria (25 listed)
- Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the following time periods prior to Visit 1:
- etanercept, adalimumab, infliximab -3 months.
- ustekinumab - 4 months
- other products - within 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 Visit 1 (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 90105Once daily for four weeks | Drug | LEO 90105 Ointment |
Primary outcome
Pharmacokinetic: Cmax of Betamethasone Dipropionate
Time frame: Day 1
The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.
Pharmacokinetic: Cmax of Betamethasone Dipropionate
Time frame: Day 7
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined
Pharmacokinetic: Cmax of Betamethasone Dipropionate
Time frame: Day 14
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined
Pharmacokinetic: AUClast of Betamethasone Dipropionate
Time frame: Day 1
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Pharmacokinetic: AUClast of Betamethasone Dipropionate
Time frame: Day 7
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Pharmacokinetic: AUClast of Betamethasone Dipropionate
Time frame: Day 14
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Pharmacokinetic: Cmax of Betamethasone 17-propionate
Time frame: Day 1
The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Pharmacokinetic: Cmax of Betamethasone 17-propionate
Time frame: Day 7
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Pharmacokinetic: Cmax of Betamethasone 17-propionate
Time frame: Day 14
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Pharmacokinetic: AUClast of Betamethasone 17-propionate
Time frame: Day 1
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Pharmacokinetic: AUClast of Betamethasone 17-propionate
Time frame: Day 7
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Pharmacokinetic: AUClast of Betamethasone 17-propionate
Time frame: Day 14
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Pharmacokinetic: Cmax of Calcipotriol
Time frame: Day 1
The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Pharmacokinetic: Cmax of Calcipotriol
Time frame: Day 7
The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Pharmacokinetic: Cmax of Calcipotriol
Time frame: Day 14
The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Pharmacokinetic: AUClast of Calcipotriol
Time frame: Day 1
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Pharmacokinetic: AUClast of Calcipotriol
Time frame: Day 7
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Pharmacokinetic: AUClast of Calcipotriol
Time frame: Day 14
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Pharmacokinetic: Cmax of MC1080
Time frame: Day 1
The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Pharmacokinetic: Cmax of MC1080
Time frame: Day 7
The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Pharmacokinetic: Cmax of MC1080
Time frame: Day 14
The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Pharmacokinetic: AUClast of MC1080
Time frame: Day 1
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Pharmacokinetic: AUClast of MC1080.
Time frame: Day 7
To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Pharmacokinetic: AUClast of MC1080.
Time frame: Day 14
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
2 secondary outcomes
Efficacy: Percentage Change in m-PASI From Baseline to Day 28
Time frame: Baseline to Day 28
Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.
Time frame: Day 28
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
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LEO 90105 in people with Psoriasis Vulgaris, 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 7 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Dec 2013). 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?
Pharmacokinetic: Cmax of Betamethasone Dipropionate (time frame: Day 1). The study lists 24 primary outcomes in all. 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.