Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Overall Improvement Rate for the Target Lesion
研究概览
简要总结
Comparison of the efficacy of LEO 90100 foam with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent obtained
- •Japanese subjects
- •Aged 20 years or above
- •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).
- •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.
- •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.
- •Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.
排除标准
- •Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to randomisation (depending on treatment)
- •Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to randomisation
- •PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion within 4 weeks prior to randomisation
- •Topical treatment of psoriasis on the areas to be treated with trial medication within 2 weeks prior to randomisation
- •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
- •Topical treatment of conditions other than psoriasis with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
- •Initiation or changes of medication that may affect psoriasis vulgaris during the trial
- •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
- •Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris
- •Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated with trial medication
- •Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight during the trial.
- •Disorders of calcium metabolism
- •Severe renal insufficiency, severe hepatic disorders or severe heart disease
- •Hypersensitivity to any components of the investigational medicinal products.
- •Cushing's disease or Addison's disease
- •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
- •History of cancer within the last 5 years (except completely cured skin cancer)
- •Current participation in any other interventional clinical trial
- •Previously randomised in this trial
- •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
研究组 & 干预措施
LEO 90100 foam
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
干预措施: LEO 90100 foam (Drug)
Dovobet® ointment
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
干预措施: Dovobet® ointment (Drug)
结局指标
主要结局
Overall Improvement Rate for the Target Lesion
时间窗: End of Week 4
Overall improvement defined as 'Substantial Resolution' of Clinical Signs or at Least 'Moderately Improved' in the General Change in the Lesion. Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'. Change in the Lesion is a 5 point scale below: * Markedly improved (best outcome) * Moderately improved * Slightly improved * Unchanged * Aggravated (worst outcome)
次要结局
- Overall Improvement Rate for the Target Lesion at Weeks 1 and 2(End of Weeks 1 and 2)
- Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4(End of Week 4)
- Number of Adverse Events(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)