Psoriasis VulgarisPhase 3NCT02668692

LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis

A Phase 3 study testing LEO 80185 gel and Dovobet ® ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects. 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 80185 gel and Dovobet ® ointment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 213 participants
Where: 1 siteJapan
Study dates: Feb 2016to Jun 2016
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

1. Informed consent has been obtained.
2. Japanese subjects
3. Aged 20 years or above
4. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA
5. A target psoriasis lesion on the scalp and on the non-scalp area of the body, each lesion of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs (redness, thickness and scaliness).
6. 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.
7. Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.

Who cannot join

1. Systemic use of biological treatments with a potential effect on psoriasis vulgaris
2. Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris
3. PUVA therapy, UVB therapy or UVA therapy
4. Topical treatment of psoriasis on the areas to be treated with trial medication
5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
6. Topical treatment of conditions other than psoriasis with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants

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7. Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris
8. Patients with any of the following disorders (a) or symptoms (b) present on the areas to be treated with trial medication: (a) viral (e.g., herpes or varicella) lesions of the skin, fungal, spirochetal 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, animal skin disease (scabies, crabs, lice, etc.) or (b) fragility of skin veins.
9. Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris.
10. Erythrodermic, exfoliative or pustular psoriasis
11. Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight
12. Known or suspected disorders of calcium metabolism associated with hypercalcaemia, or albumin-corrected serum calcium above the reference range
13. Known or suspected severe renal insufficiency, severe hepatic disorders or severe heart disease.
14. Known or suspected hypersensitivity to any components of the investigational products.
15. Clinical signs or symptoms of Cushing's disease or Addison's disease
16. Treatment with any non-marketed drug substance
17. Current participation in any other interventional clinical trial
18. Previously randomised in this trial
19. Females who are pregnant, wishing to become pregnant or are breast-feeding

Trial locations and contacts

1 site in 1 country.

Japan1 site

Medical Corporation Bikyukai Kokubu Dermatology
Kitami-shi, Hokkaido, 090-0832

Other trials in Japan

About this study

Official title: Efficacy and Safety of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris

To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Read the detailed description

A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 80185 gel versus Dovobet® ointment in Japanese subjects with psoriasis vulgaris.

Conditions: Psoriasis Vulgaris
Being tested: LEO 80185 gel, Dovobet ® ointment
Keywords: LEO 80185 gel, calcipotriol, betamethasone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LEO 80185 gelDrug
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
Dovobet ® ointmentDrug
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions

Study groups in NCT02668692
Study group	Role	What they receive
LEO 80185 gel	Experimental	Not described Receives: Drug: LEO 80185 gel
Dovobet ® ointment	Active comparator	Not described Receives: Drug: Dovobet ® ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp
'Overall improvement' for the target lesion on the scalp, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion.
'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion.
Measured: End of Week 4

Secondary outcomes (2)

Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body
'Overall Improvement' for the target lesion on the non-scalp area of the body, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion.
'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion.
Measured: End of Week 4
The Change in the Sum of the Scores (Total Sign Score) for the Severity of the 3 Clinical Signs:Thickness, Scaliness, Redness From Baseline to End of Week 4 (Visit 1-4) for Each Target Lesion.
Severity was recorded for each of the 3 clinical signs according to the 9-point scales* below.
*intermediate intervals (0.5, 1.5, 2.5, 3.5) serve as mid points between the defined grades.
Redness 0=none (no erythema)
1. slight (faint erythema, pink to very light red)
2. mild (definite light red erythema)
3. moderate (dark red erythema)
4. severe (very dark red erythema)
Thickness 0=none (no plaque elevation)
1. slight (slight, barely perceptible elevation)
2. mild (definite elevation but not thick)
3. moderate (definite elevation, thick plaque with sharp edge)
4. severe (very thick plaque with sharp edge)
Scaliness 0=none (no scaling)
1. slight (sparse, fine scale, lesions only partially covered)
2. mild (coarser scales, most of lesions covered)
3. moderate (entire lesion covered with coarse scales)
4. severe (very thick coarse scales, possibly fissured)
Negative change denotes a decrease in the score and therefore a decrease in disease severity.
Measured: From Baseline to end of Week 4 (Visit 1-4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Jun 2016

First posted29 Jan 2016 (estimated)
Study startFeb 2016
Primary completionJun 2016
Study completionJun 2016

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: None (open label)
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02668692
Sponsor's protocol ID: LP0076-1128
Status last verified: Jul 2021
First submitted: 26 Jan 2016
Last updated: 10 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
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RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
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Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
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RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
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All Psoriasis Vulgaris trials

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: Efficacy and Safety of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris
ClinicalTrials.gov ID: NCT02668692
Acronym / sponsor ID: LP0076-1128
Conditions: Psoriasis Vulgaris
Keywords: LEO 80185 gel, calcipotriol, betamethasone
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Collaborators: CMIC Co, Ltd. Japan
Study start: Feb 2016
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 29 Jan 2016 (estimated)
Results: Posted 27 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Detailed description

A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 80185 gel versus Dovobet® ointment in Japanese subjects with psoriasis vulgaris.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LEO 80185 gel	Experimental	Drug: LEO 80185 gel
Dovobet ® ointment	Active comparator	Drug: Dovobet ® ointment

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

1. Informed consent has been obtained.
2. Japanese subjects
3. Aged 20 years or above
4. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA
5. A target psoriasis lesion on the scalp and on the non-scalp area of the body, each lesion of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs (redness, thickness and scaliness).

Key exclusion criteria (19 listed)

1. Systemic use of biological treatments with a potential effect on psoriasis vulgaris
2. Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris
3. PUVA therapy, UVB therapy or UVA therapy
4. Topical treatment of psoriasis on the areas to be treated with trial medication
5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants

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 80185 gelcalcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Drug	LEO 80185 gel
Dovobet ® ointmentcalcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions	Drug	Dovobet ® ointment

Primary outcome

Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp
Time frame: End of Week 4
'Overall improvement' for the target lesion on the scalp, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion. 'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion.

2 secondary outcomes

Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body
Time frame: End of Week 4
The Change in the Sum of the Scores (Total Sign Score) for the Severity of the 3 Clinical Signs:Thickness, Scaliness, Redness From Baseline to End of Week 4 (Visit 1-4) for Each Target Lesion.
Time frame: From Baseline to end of Week 4 (Visit 1-4)

Results and safety

Results posted to the registry on 27 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LEO 80185 Gel	101	100
Dovobet® Ointment	105	105

Primary outcome: Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp

Time frame: End of Week 4. Count of participants. Unit: Participants

Measure	LEO 80185 Gel n = 101	Dovobet® Ointment n = 105
Overall improvement	99	101
Not overall improvement	2	4

LEO 80185 Gel vs Dovobet® Ointment: Odds Ratio (OR): 1.96 (95% CI 0.35 to 10.95), p =0.68, Fisher Exact
LEO 80185 Gel vs Dovobet® Ointment: Odds Ratio (OR): 1.92 (95% CI 0.34 to 10.72), p =0.68, Fisher Exact

Population analysed: All 206 randomised subjects are included in the full analysis set (FAS): 101 in the LEO 80185 group and 105 in the Dovobet® group. The per protocol analysis set (PPAS) was defined by excluding subjects from the FAS based on a review of protocol deviations. PPAS includes 94 subjects in the LEO 80185 group and 100 in the Dovobet® group.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of Informed Consent Form up to 14 days after last visit (Week 4).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LEO 80185 Gel	1 of 101 (1%)	13 of 101 (12.9%)	0 of 101
Dovobet® Ointment	0 of 105 (0%)	9 of 105 (8.6%)	0 of 105

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

Related trials for Psoriasis Vulgaris

Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
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RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
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RecruitingPhase 4
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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.

Medical Expert study director

LEO Pharma

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 80185 gel and Dovobet ® ointment 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 19 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 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 27 Jul 2021). 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?

Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp (time frame: End of Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02668692.

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.