Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Psoriasis Vulgaris

Treatments: Drug: LEO 90100 foam; Drug: Dovobet® ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03806790

LP0053-1422

Details and patient eligibility

About

Comparison of the efficacy of LEO 90100 foam 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 90100 foam versus Dovobet® ointment (both treatments containing calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with psoriasis vulgaris.

Enrollment: 182 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Signed and dated informed consent 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 (excluding psoriasis on the face/genitals/skin folds).
5. A target psoriasis lesion of at least mild severity on the body of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesion must not be on the scalp, face, genitals or skin folds.
6. Women of childbearing potential must have a negative pregnancy test at Day 1 and agree to use an adequate methods of birth control during the trial.
7. Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.

Key Exclusion Criteria:

1. Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to randomisation (depending on treatment)
2. Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to randomisation
3. PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion within 4 weeks prior to randomisation
4. Topical treatment of psoriasis on the areas to be treated with trial medication within 2 weeks prior to randomisation
5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
6. Topical treatment of conditions other than psoriasis with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
7. Initiation or changes of medication that may affect psoriasis vulgaris during the trial
8. Patients with certain disorders or symptoms present on the areas to be treated with trial medication: viral lesions of the skin, infections, skin manifestations, or fragility of skin veins
9. Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris
10. Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated with trial medication
11. Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight during the trial.
12. Disorders of calcium metabolism
13. Severe renal insufficiency, severe hepatic disorders or severe heart disease
14. Hypersensitivity to any components of the investigational medicinal products.
15. Cushing's disease or Addison's disease
16. Subjects who have received treatment with any non-marketed drug substance within the 4 weeks prior to randomisation, or longer if for certain biological treatments
17. History of cancer within the last 5 years (except completely cured skin cancer)
18. Current participation in any other interventional clinical trial
19. Previously randomised in this trial
20. Women who are pregnant, wishing to become pregnant or are breast-feeding
21. Chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance
22. Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

LEO 90100 foam

Experimental group

Description:

calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g

Treatment:

Drug: LEO 90100 foam

Dovobet® ointment

Active Comparator group

Description:

calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g

Treatment:

Drug: Dovobet® ointment