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

NCT ID: NCT03806790

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-24
• Study Completion Date: 2019-06-10

Brief Summary

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

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LEO 90100 foam

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

Group Type: EXPERIMENTAL

LEO 90100 foam

Intervention Type: DRUG

Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.

Dovobet® ointment

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

Group Type: ACTIVE_COMPARATOR

Dovobet® ointment

Intervention Type: DRUG

Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.

Interventions

LEO 90100 foam

Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.

Intervention Type: DRUG

Dovobet® ointment

Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.

Intervention Type: DRUG

Other Intervention Names

Enstilar® Foam

Eligibility Criteria

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.

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

Leo Pharma Investigational Site

Fukutsu, Fukuoka, Japan

Leo Pharma Investigational Site

Obihiro, Hokkaido, Japan

Leo Pharma Investigational Site

Sapporo, Hokkaido, Japan

Leo Pharma Investigational Site

Sapporo, Hokkaido, Japan

Leo Pharma Investigational Site

Sapporo, Hokkaido, Japan

Leo Pharma Investigational Site

Nonoichi, Ishikawa-ken, Japan

Leo Pharma Investigational Site

Kawasaki, Kanagawa, Japan

Leo Pharma Investigational Site

Yokohama, Kanagawa, Japan

Leo Pharma Investigational Site

Sendai, Miyagi, Japan

Leo Pharma Investigational Site

Saitama-shi, Saitama, Japan

Leo Pharma Investigational Site

Itabashi-ku, Tokyo, Japan

Leo Pharma Investigational Site

Kita-ku, Tokyo, Japan

Leo Pharma Investigational Site

Koto-Ku, Tokyo, Japan

Leo Pharma Investigational Site

Minato-Ku, Tokyo, Japan

Leo Pharma Investigational Site

Setagaya City, Tokyo, Japan

Leo Pharma Investigational Site

Setagaya City, Tokyo, Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

LP0053-1422

Identifier Type: -

Identifier Source: org_study_id