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

Last updated: February 21, 2025
Sponsor: LEO Pharma
Overall Status: Completed

Phase

3

Condition

Scalp Disorders

Rosacea

Rash

Treatment

Dovobet ® ointment

LEO 80185 gel

Clinical Study ID

NCT02668692
LP0076-1128
  • Ages > 20
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 lessthan 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 eachof the clinical signs (redness, thickness and scaliness).
  1. Females of childbearing potential must have a negative result for a urinepregnancy test at Day 1 (Visit 1) and must agree to use an adequate method ofbirth control.
  1. Able to communicate with the (sub)investigator and understand and comply withthe requirements of the trial.

Exclusion

Exclusion Criteria:

  1. Systemic use of biological treatments with a potential effect on psoriasisvulgaris
  1. Systemic treatments with all therapies other than biological treatments with apotential 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 vitaminD 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 affectpsoriasis vulgaris
  1. Patients with any of the following disorders (a) or symptoms (b) present on theareas to be treated with trial medication: (a) viral (e.g., herpes orvaricella) lesions of the skin, fungal, spirochetal or bacterial skininfections, parasitic infections, skin manifestations in relation to syphilisor 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 psoriasisvulgaris.
  1. Erythrodermic, exfoliative or pustular psoriasis
  1. Planned excessive exposure of areas to be treated with trial medication toeither natural or artificial sunlight
  1. Known or suspected disorders of calcium metabolism associated withhypercalcaemia, or albumin-corrected serum calcium above the reference range
  1. Known or suspected severe renal insufficiency, severe hepatic disorders orsevere heart disease.
  1. Known or suspected hypersensitivity to any components of the investigationalproducts.
  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

Study Design

Total Participants: 213
Treatment Group(s): 2
Primary Treatment: Dovobet ® ointment
Phase: 3
Study Start date:
February 01, 2016
Estimated Completion Date:
June 30, 2016

Study 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.

Connect with a study center

  • Medical Corporation Bikyukai Kokubu Dermatology

    Kitami-shi, Hokkaido 090-0832
    Japan

    Site Not Available

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