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LEO 90105 Ointment in Japanese Subjects With Psoriasis

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: LEO 90105 = calcipotriol + betamethasone dipropionate (Drug); Dovonex® = calcipotriol (Drug); Rinderon® - DP = betamethasone dipropionate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Akira Ozawa, MD, Professor, Principal Investigator, Affiliation: Tokai University School of Medicine

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)

Secondary outcome:

Change From Baseline in Target Lesion Assessment

Physician's Global Assessment of Psoriasis

Change in mPASI From Baseline to Week 1

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

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

- Planned initiation of, or changes in, concomitant medication that may affect

psoriasis vulgaris (e. g., beta-blockers, antimalaria drugs, lithium and Angiotensin Converting Enzyme (ACE) inhibitors) during the study.

- Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis.

- 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 on the trunk/limbs.

- Planned excessive exposure of area(s) to be treated with study medication to either

natural or artificial sunlight (including tanning booths, sun lamps, etc) during the study.

- Known or suspected disorders of calcium metabolism associated with hypercalcaemia, or

albumin-corrected serum calcium above the reference range from the sample taken at the Washout/Screening Visit.

- Known or suspected severe renal insufficiency, severe hepatic disorders or severe

heart disease.

- Known or suspected hypersensitivity to any components of the investigational

products.

- Clinical signs or symptoms of Cushing's disease or Addison's disease

- 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 weeks prior to randomisation, or longer if the class of substance requires a longer washout as defined in exclusion criterion number 1 for 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 randomisation in this study.

- Hospitalised patients.

Locations and Contacts

Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan
Additional Information

Clinical Trials at LEO Pharma

Starting date: July 2011
Last updated: March 25, 2015

Page last updated: August 23, 2015

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