Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

182

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Jan 2019

Shorter than P25 for phase_3

Geographic Reach

1 country

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5 months study duration

First Submitted

Initial submission to the registry

January 15, 2019

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed

8 days until next milestone

Study Start

First participant enrolled

January 24, 2019

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2019

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

December 16, 2020

Completed

Last Updated

March 10, 2025

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

January 15, 2019

Results QC Date

September 29, 2020

Last Update Submit

February 21, 2025

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

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)
End of Week 4

Secondary Outcomes (3)

Overall Improvement Rate for the Target Lesion at Weeks 1 and 2
End of Weeks 1 and 2
Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4
End of Week 4
Number of Adverse Events
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

Study Arms (2)

LEO 90100 foam

EXPERIMENTAL

calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g

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

Drug: Dovobet® ointment

Interventions

LEO 90100 foamDRUG

Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.

Also known as: Enstilar® Foam

LEO 90100 foam

Dovobet® ointmentDRUG

Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.

Dovobet® ointment

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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
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
+7 more criteria

Contact the study team to confirm eligibility.