A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
Stable Plaque Psoriasis
About this trial
This is an interventional treatment trial for Stable Plaque Psoriasis focused on measuring Stable plaque psoriasis, Vitamin D analogue, Native Chinese subjects
Eligibility Criteria
Inclusion Criteria: Chinese native Aged 18 or over A clinical diagnosis of stable plaque psoriasis for at least 6 months Stable plaque psoriasis on the trunk and/or limbs (excluding psoriasis on the face, scalp, genitals, and skin folds) involving 2-30% of the body surface at Day 1 (Visit 2) of the trial. Having a Physician Global Assessment of at least 'mild' at Day 1 (Visit 2) An mPASI score of at least 2 on the trunk and/or limbs at Day 1 (Visit 2) Women of childbearing potential must use an adequate form of birth control throughout the trial and for at least 8 weeks after last administration of IMP Male subjects with a female partner of childbearing potential must use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) Having a signed and dated informed consent. Exclusion Criteria: Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to treatment assignment (depending on treatment) Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to treatment assignment Psoralen combined with ultraviolet A therapy (PUVA) within 4 weeks prior to treatment assignment Systemic treatment with Apremilast within 4 weeks prior to treatment assignment Ultraviolet B (UVB) therapy within 2 weeks prior to treatment assignment Topical treatment of psoriasis with strong corticosteroids within 2 weeks prior to treatment assignment Topical treatment of psoriasis with traditional Chinese medicine within 2 weeks prior to treatment assignment Treatment with any non-marketed drug substance (any agent which has not yet been made available for clinical use) within 4 weeks/5 half-lives prior to treatment assignment Any other topical treatment that could affect plaque psoriasis within 2 weeks prior to treatment assignment Current diagnosis of guttate, erythrodermic, exfoliative, pustular or unstable psoriasis Patients with any of the following conditions present on any skin area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds Disorders of calcium metabolism Renal insufficiency, hepatic disorders or severe heart disease Cushing's disease or Addison's disease Known or suspected hypersensitivity to any component(s) of the investigational medicinal product (IMP) Current participation in any other interventional clinical trial Previously screened in this trial Participation in another clinical trial within 4 weeks prior to treatment assignment Women who are pregnant, wishing to become pregnant or are breast-feeding Chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance 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
Sites / Locations
- First Hospital of Bengbu Medical College
- First Hospital of Bengbu Medical CollegeRecruiting
- Peking Univ People's HospitalRecruiting
- Beijing Friendship HospitalRecruiting
- Chongqing Hospital, Traditional Chinese Medicine
- Chongqing Hospital, Traditional Chinese MedicineRecruiting
- First Hospital of Chongqing Medical UniversityRecruiting
- Guangdong Provincial People's HospitalRecruiting
- Derma Hospital of Southern Medical University
- Dermatology Hospital of Southern Medical UniversityRecruiting
- Shenzhen People's HospitalRecruiting
- Chengde Medical College HospitalRecruiting
- Hebei Medical University, First HospitalRecruiting
- First People's Hospital NanyangRecruiting
- Shiyan Renmin Hospital
- Shiyan Renmin HospitalRecruiting
- Union Hospital Tongji Medical CollegeRecruiting
- Central South University, Second Xiangya Hospital
- The Second Xiangya Hospital of Central South UniversityRecruiting
- Baotou Central HospitalRecruiting
- IMMU Baogang HospitalRecruiting
- Subei People's Hospital, Jiangsu ProvinceRecruiting
- Jiangsu University Hospital
- Jiangsu University HospitalRecruiting
- First Hosp of Jilin University
- First Hospital of Jilin UniversityRecruiting
- First Hospital Xi'an Jiaotong UniversityRecruiting
- Shengli Oilfield Central HospitalRecruiting
- Jinan Central HospitalRecruiting
- Dermatology Hospital of Shandong First Medical University
- Shanghai Dermatology HospitalRecruiting
- West China Hospital, Sichuan UniversityRecruiting
- Suining Central HospitalRecruiting
- First Hospital of Zhejiang University
- Hangzhou Third People's Hospital
- Second Hospital of Zhejiang University
- Second Hospital of Zhejiang UniversityRecruiting
- Zhejiang Provincial People's HospitalRecruiting
- Sir Run Run Shaw Hospital
- The First Hospital of JiaxingRecruiting
- Ningbo No.2 HospitalRecruiting
- Ningbo First HospitalRecruiting
- First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
LEO 90100
Daivobet® ointment
The subjects will receive LEO 90100 foam once daily for 4 weeks.
The subjects will receive Daivobet® ointment once daily for 4 weeks.