LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis

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LEO Pharma

Status and phase

Completed
Phase 3

Conditions

Psoriasis Vulgaris

Treatments

Drug: LEO 80185 gel
Drug: Dovobet ® ointment

Study type

Interventional

Funder types

Industry

Identifiers

NCT02668692
LP0076-1128

Details and patient eligibility

About

To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Full description

A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 80185 gel versus Dovobet® ointment in Japanese subjects with psoriasis vulgaris.

Enrollment

213 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. Informed consent has been obtained.
    1. Japanese subjects
    1. Aged 20 years or above
    1. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA
    1. A target psoriasis lesion on the scalp and on the non-scalp area of the body, each lesion of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs (redness, thickness and scaliness).
    1. Females of childbearing potential must have a negative result for a urine pregnancy test at Day 1 (Visit 1) and must agree to use an adequate method of birth control.
    1. Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.

Exclusion criteria

    1. Systemic use of biological treatments with a potential effect on psoriasis vulgaris
    1. Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris
    1. PUVA therapy, UVB therapy or UVA therapy
    1. Topical treatment of psoriasis on the areas to be treated with trial medication
    1. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
    1. Topical treatment of conditions other than psoriasis with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
    1. Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris
    1. Patients with any of the following disorders (a) or symptoms (b) present on the areas to be treated with trial medication: (a) viral (e.g., herpes or varicella) lesions of the skin, fungal, spirochetal 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, animal skin disease (scabies, crabs, lice, etc.) or (b) fragility of skin veins.
    1. Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris.
    1. Erythrodermic, exfoliative or pustular psoriasis
    1. Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight
    1. Known or suspected disorders of calcium metabolism associated with hypercalcaemia, or albumin-corrected serum calcium above the reference range
    1. Known or suspected severe renal insufficiency, severe hepatic disorders or severe heart disease.
    1. Known or suspected hypersensitivity to any components of the investigational products.
    1. Clinical signs or symptoms of Cushing's disease or Addison's disease
    1. Treatment with any non-marketed drug substance
    1. Current participation in any other interventional clinical trial
    1. Previously randomised in this trial
    1. Females who are pregnant, wishing to become pregnant or are breast-feeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

213 participants in 2 patient groups

LEO 80185 gel
Experimental group
Treatment:
Drug: LEO 80185 gel
Dovobet ® ointment
Active Comparator group
Treatment:
Drug: Dovobet ® ointment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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