Clinical trial NCT02668692: LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis
Official title: Efficacy and Safety of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Keywords: LEO 80185 gel, calcipotriol, betamethasone
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: CMIC Co, Ltd. Japan
First posted: 2016-01-29
Enrollment: 213
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: To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 1. Informed consent has been obtained.
* 2. Japanese subjects
* 3. Aged 20 years or above
* 4. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA
* 5. 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).
* 6. 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.
* 7. 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
* 2. Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris
* 3. PUVA therapy, UVB therapy or UVA therapy
* 4. Topical treatment of psoriasis on the areas to be treated with trial medication
* 5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
* 6. Topical treatment of conditions other than psoriasis with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
* 7. Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris
* 8. 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.
* 9. Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris.
* 10. Erythrodermic, exfoliative or pustular psoriasis
* 11. Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight
* 12. Known or suspected disorders of calcium metabolism associated with hypercalcaemia, or albumin-corrected serum calcium above the reference range
* 13. Known or suspected severe renal insufficiency, severe hepatic disorders or severe heart disease.
* 14. Known or suspected hypersensitivity to any components of the investigational products.
* 15. Clinical signs or symptoms of Cushing's disease or Addison's disease
* 16. Treatment with any non-marketed drug substance
* 17. Current participation in any other interventional clinical trial
* 18. Previously randomised in this trial
* 19. Females who are pregnant, wishing to become pregnant or are breast-feeding

Primary outcomes:
measure: Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp
timeFrame: End of Week 4
Secondary outcomes:
measure: Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body
timeFrame: End of Week 4
measure: The Change in the Sum of the Scores (Total Sign Score) for the Severity of the 3 Clinical Signs:Thickness, Scaliness, Redness From Baseline to End of Week 4 (Visit 1-4) for Each Target Lesion.
timeFrame: From Baseline to end of Week 4 (Visit 1-4)
Other outcomes:
Locations:
city: Kitami-shi
country: Japan
facility: Medical Corporation Bikyukai Kokubu Dermatology
state: Hokkaido
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: