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LEO 90105 Ointment in Japanese Subjects With Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

LEO 90105 Ointment in Japanese Subjects With Psoriasis

Efficacy and Safety of LEO 90105 Ointment (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris

NCT01422434•LEO Pharma

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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).

Exclusion Criteria

•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.
•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.
+15 more criteria

Locations (1)

Tokai University School of Medicine

Isehara, Kanagawa, Japan

Key Dates

Start Date

July 1, 2011

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

March 12, 2025

Enrollment

676

ACTUAL participants

Conditions

Psoriasis

Interventions

LEO 90105 = calcipotriol + betamethasone dipropionate

DRUG

Dovonex® = calcipotriol

DRUG

Rinderon® - DP = betamethasone dipropionate

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

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Psoriasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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LEO 90105 Ointment in Japanese Subjects With Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments