Psoriasis VulgarisPhase 3NCT03806790

Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris

A Phase 3 study testing LEO 90100 foam and Dovobet® ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 16 sites 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

Comparison of the efficacy of LEO 90100 foam 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 90100 foam and Dovobet® ointment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 182 participants
Where: 16 sitesJapan
Study dates: 24 Jan 2019to 10 Jun 2019
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

Signed and dated informed consent obtained
Japanese subjects
Aged 20 years or above
Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA (excluding psoriasis on the face/genitals/skin folds).
A target psoriasis lesion of at least mild severity on the body of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesion must not be on the scalp, face, genitals or skin folds.
Women of childbearing potential must have a negative pregnancy test at Day 1 and agree to use an adequate methods of birth control during the trial.
Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.

Who cannot join

Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to randomisation (depending on treatment)
Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to randomisation
PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion within 4 weeks prior to randomisation
Topical treatment of psoriasis on the areas to be treated with trial medication within 2 weeks prior to randomisation
Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
Topical treatment of conditions other than psoriasis with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation

Show all 22Show fewer

Initiation or changes of medication that may affect psoriasis vulgaris during the trial
Patients with certain disorders or symptoms present on the areas to be treated with trial medication: viral lesions of the skin, infections, skin manifestations, or fragility of skin veins
Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris
Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated with trial medication
Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight during the trial.
Disorders of calcium metabolism
Severe renal insufficiency, severe hepatic disorders or severe heart disease
Hypersensitivity to any components of the investigational medicinal products.
Cushing's disease or Addison's disease
Subjects who have received treatment with any non-marketed drug substance within the 4 weeks prior to randomisation, or longer if for certain biological treatments
History of cancer within the last 5 years (except completely cured skin cancer)
Current participation in any other interventional clinical trial
Previously randomised in this trial
Women who are pregnant, wishing to become pregnant or are breast-feeding
Chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance
Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Japan16 sites

Leo Pharma Investigational Site
Fukutsu, Fukuoka, 811-3217
Leo Pharma Investigational Site
Kawasaki, Kanagawa, 213-0001
Leo Pharma Investigational Site
Kita-ku, Tokyo, 115-0045
Leo Pharma Investigational Site
Koto-Ku, Tokyo, 136-0074
Leo Pharma Investigational Site
Minato-Ku, Tokyo, 108-0014
Leo Pharma Investigational Site
Nonoichi, Ishikawa-ken, 921-8801
Leo Pharma Investigational Site
Obihiro, Hokkaido, 080-0013
Leo Pharma Investigational Site
Saitama-shi, Saitama, 330-0854
Leo Pharma Investigational Site
Sapporo, Hokkaido, 004-0063
Leo Pharma Investigational Site
Sapporo, Hokkaido, 006-0814
Leo Pharma Investigational Site
Sapporo, Hokkaido, 060-0807
Leo Pharma Investigational Site
Sendai, Miyagi, 981-3133
Leo Pharma Investigational Site
Setagaya City, Tokyo, 158-0094
Leo Pharma Investigational Site
Setagaya City, Tokyo, 158-0097
Leo Pharma Investigational Site
tabashi City, Tokyo, 173-8605
Leo Pharma Investigational Site
Yokohama, Kanagawa, 220-6208

Other trials in Japan

About this study

Comparison of the efficacy of LEO 90100 foam 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 90100 foam versus Dovobet® ointment (both treatments containing calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with psoriasis vulgaris.

Conditions: Psoriasis Vulgaris
Being tested: LEO 90100 foam, Dovobet® ointment

What participants receive

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

LEO 90100 foamDrug
Also called Enstilar® Foam
Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.
Dovobet® ointmentDrug
Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.

Study groups in NCT03806790
Study group	Role	What they receive
LEO 90100 foam	Experimental	calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g Receives: Drug: LEO 90100 foam
Dovobet® ointment	Active comparator	calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g Receives: Drug: Dovobet® ointment

What is being measured

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

Overall Improvement Rate for the Target Lesion
Overall improvement defined as 'Substantial Resolution' of Clinical Signs 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 target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'.
Change in the Lesion is a 5 point scale below:
- Markedly improved (best outcome)
- Moderately improved
- Slightly improved
- Unchanged
- Aggravated (worst outcome)
Measured: End of Week 4

Secondary outcomes (3)

Overall Improvement Rate for the Target Lesion at Weeks 1 and 2
Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion.
Change in the Lesion is a 5 point scale below:
- Markedly improved (best outcome)
- Moderately improved
- Slightly improved
- Unchanged
- Aggravated (worst outcome)
Measured: End of Weeks 1 and 2
Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4
The change in the total sign score from Week 0 to Week 4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion.
The severity for each of the 3 clinical signs was recorded according to a 9-point scale that ranges from a score of 0 to 4 in increments of 0.5; the severities are scored from low to high with 0 = none and 4 = severe. The sum of the 3 total sign scores could range from 0 (best) to 12 (worse). The greater the negative value for the change means a better outcome.
Negative change denotes a decrease in the score and therefore a decrease in disease severity.
Measured: End of Week 4
Number of Adverse Events
Number of treatment emergent adverse events (TEAEs). 14-day follow-up of TEAEs was only required if the TEAE was present at the last visit, and was of possible or probable relationship to trial medication.
Measured: Treatment Emergent Adverse Events were assessed from Day 1 to end of Week 4, if Treatment Emergent Adverse Events were noted, they were followed for an additional 14 days

Timeline

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

24 Jan 201910 Jun 2019

First posted16 Jan 2019
Study start24 Jan 2019
Primary completion10 Jun 2019
Study completion10 Jun 2019

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: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03806790
Sponsor's protocol ID: LP0053-1422
Status last verified: Nov 2020
First submitted: 15 Jan 2019
Last updated: 10 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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
Psoriasis Vulgaris
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 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
ClinicalTrials.gov ID: NCT03806790
Acronym / sponsor ID: LP0053-1422
Conditions: Psoriasis Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: 24 Jan 2019 (actual)
Primary completion: 10 Jun 2019 (actual)
Study completion: 10 Jun 2019 (actual)
First posted: 16 Jan 2019 (actual)
Results: Posted 16 Dec 2020

Clinical summary

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

Comparison of the efficacy of LEO 90100 foam with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Detailed description

Study design

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

Arm	Type	Receives
LEO 90100 foam	Experimental	Drug: LEO 90100 foamcalcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
Dovobet® ointment	Active comparator	Drug: Dovobet® ointmentcalcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g

Who may qualify

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

Key inclusion criteria (7 listed)

Signed and dated informed consent obtained
Japanese subjects
Aged 20 years or above
Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA (excluding psoriasis on the face/genitals/skin folds).
A target psoriasis lesion of at least mild severity on the body of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesion must not be on the scalp, face, genitals or skin folds.

Key exclusion criteria (22 listed)

Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to randomisation (depending on treatment)
Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to randomisation
PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion within 4 weeks prior to randomisation
Topical treatment of psoriasis on the areas to be treated with trial medication within 2 weeks prior to randomisation
Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3 analogues, potent corticosteroids or immunosuppressants 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
LEO 90100 foamAlso: Enstilar® FoamOnce daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.	Drug	LEO 90100 foam
Dovobet® ointmentOnce daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.	Drug	Dovobet® ointment

Primary outcome

Overall Improvement Rate for the Target Lesion
Time frame: End of Week 4
Overall improvement defined as 'Substantial Resolution' of Clinical Signs 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 target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'. Change in the Lesion is a 5 point scale below: * Markedly improved (best outcome) * Moderately improved * Slightly improved * Unchanged * Aggravated (worst outcome)

3 secondary outcomes

Overall Improvement Rate for the Target Lesion at Weeks 1 and 2
Time frame: End of Weeks 1 and 2
Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4
Time frame: End of Week 4
Number of Adverse Events
Time frame: Treatment Emergent Adverse Events were assessed from Day 1 to end of Week 4, if Treatment Emergent Adverse Events were noted, they were followed for an additional 14 days

Results and safety

Results posted to the registry on 16 Dec 2020, 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 90100 Foam	87	87
Dovobet® Ointment	95	95

Primary outcome: Overall Improvement Rate for the Target Lesion

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

Measure	LEO 90100 Foam n = 87	Dovobet® Ointment n = 95
Value	86	89

LEO 90100 Foam vs Dovobet® Ointment: Odds Ratio (OR): 5.80 (95% CI 0.68 to 49.16), p = 0.120, Fisher Exact

Population analysed: The primary endpoint was analysed for the full analysis set. Rates of subjects with the event defined by the primary endpoint, 'overall improvement rate' for the target lesion at Visit 4 (end of Week 4), were compared between treatment groups by means of Fisher's exact test. Estimated rates, odds ratio, and its 95% CI were presented, together with the p-value from Fisher's exact test.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LEO 90100 Foam	0 of 87 (0%)	15 of 87 (17.2%)	0 of 87
Dovobet® Ointment	0 of 95 (0%)	19 of 95 (20%)	0 of 95

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.
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

16 sites 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 90100 foam and Dovobet® ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 16 sites 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 22 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 16 sites 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 16 Dec 2020). 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?

Overall Improvement Rate for the Target Lesion (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 NCT03806790.

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.