Clinical trial NCT01422434: LEO 90105 Ointment in Japanese Subjects With Psoriasis
Official title: Efficacy and Safety of LEO 90105 Ointment (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: A national
multi-centre
prospective
randomised
double-blind
active-controlled
3-arm
parallel group
4 week study
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2011-08-24
Enrollment: 676
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Change From Baseline in Target Lesion Assessment
timeFrame: Baseline to Week 4
measure: Physician's Global Assessment of Psoriasis
timeFrame: Week 4
measure: Change in mPASI From Baseline to Week 1
timeFrame: Baseline to Week 1
Other outcomes:
Locations:
city: Isehara
country: Japan
facility: Tokai University School of Medicine
state: Kanagawa
Study officials:
affiliation: Tokai University School of Medicine
name: Akira Ozawa, MD, Professor
role: PRINCIPAL_INVESTIGATOR
References: