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.
Minimum age: 20 Years.
Maximum age: N/A.
- 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 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).
- 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).
- PUVA therapy, UVB therapy or 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
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 ran-domisation.
- 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 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
- 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
- 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
- Known or suspected hypersensitivity to any components of the investigational
- 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
- Females who are pregnant, wishing to become pregnant during the study, or are
- 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.