Clinical trial NCT03806790: Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
Official title: Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2019-01-16
Enrollment: 182
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: 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.

Eligibility 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

Primary outcomes:
measure: Overall Improvement Rate for the Target Lesion
timeFrame: End of Week 4
Secondary outcomes:
measure: Overall Improvement Rate for the Target Lesion at Weeks 1 and 2
timeFrame: End of Weeks 1 and 2
measure: Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4
timeFrame: End of Week 4
measure: Number of Adverse Events
timeFrame: Treatment Emergent Adverse Events were assessed from Day 1 to end of Week 4, if Treatment Emergent Adverse Events were noted, they were followed for an additional 14 days
Other outcomes:
Locations:
city: Fukutsu
country: Japan
facility: Leo Pharma Investigational Site
state: Fukuoka
city: Obihiro
country: Japan
facility: Leo Pharma Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Leo Pharma Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Leo Pharma Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Leo Pharma Investigational Site
state: Hokkaido
city: Nonoichi
country: Japan
facility: Leo Pharma Investigational Site
state: Ishikawa
city: Kawasaki
country: Japan
facility: Leo Pharma Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Leo Pharma Investigational Site
state: Kanagawa
city: Sendai
country: Japan
facility: Leo Pharma Investigational Site
state: Miyagi
city: Saitama-shi
country: Japan
facility: Leo Pharma Investigational Site
state: Saitama
city: Itabashi-ku
country: Japan
facility: Leo Pharma Investigational Site
state: Tokyo
city: Kita-ku
country: Japan
facility: Leo Pharma Investigational Site
state: Tokyo
city: Koto-Ku
country: Japan
facility: Leo Pharma Investigational Site
state: Tokyo
city: Minato-Ku
country: Japan
facility: Leo Pharma Investigational Site
state: Tokyo
city: Setagaya
country: Japan
facility: Leo Pharma Investigational Site
state: Tokyo
city: Setagaya
country: Japan
facility: Leo Pharma Investigational Site
state: Tokyo
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: