A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)
研究概览
简要总结
The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 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 has been obtained
- •Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
- •Age 18 years or above
- •Outpatients
- •Female subjects must be of either
- •non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,
- •child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
排除标准
- •Female subjects who are breast feeding
- •Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- •Etanercept - within 4 weeks prior to randomisation and during the trial
- •Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial
- •Ustekinumab - within 16 weeks prior to randomisation and during the trial
- •Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer)
- •Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial,
- •Subjects using phototherapy within the following time periods prior to randomisation and during the trial:
- •PUVA: 4 weeks
- •UVB: 2 weeks
- •Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:
- •Potent or very potent (WHO group III-IV) corticosteroids
- •Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:
- •WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
- •Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid
- •Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
- •Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial
- •Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
研究组 & 干预措施
Calcipotriol aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g, topical
干预措施: Aerosol spray vehicle (Drug)
Calcipotriol aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g, topical
干预措施: LEO 90100 aerosol foam (Drug)
LP0113 aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Aerosol spray vehicle (Drug)
LP0113 aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: LEO 90100 aerosol foam (Drug)
LP0113 aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Betamethasone dipropionate aerosol spray (Drug)
LP0113 aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Calcipotriol aerosol spray (Drug)
LP0113 aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Daivobet® gel (Drug)
Aerosol spray vehicle
No active ingredient, topical
干预措施: LP0113 aerosol spray (Drug)
Aerosol spray vehicle
No active ingredient, topical
干预措施: LEO 90100 aerosol foam (Drug)
Aerosol spray vehicle
No active ingredient, topical
干预措施: Betamethasone dipropionate aerosol spray (Drug)
Aerosol spray vehicle
No active ingredient, topical
干预措施: Calcipotriol aerosol spray (Drug)
Aerosol spray vehicle
No active ingredient, topical
干预措施: Daivobet® gel (Drug)
LEO 90100 aerosol foam
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: LP0113 aerosol spray (Drug)
LEO 90100 aerosol foam
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Aerosol spray vehicle (Drug)
LEO 90100 aerosol foam
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Betamethasone dipropionate aerosol spray (Drug)
LEO 90100 aerosol foam
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Calcipotriol aerosol spray (Drug)
LEO 90100 aerosol foam
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Daivobet® gel (Drug)
Betamethasone dipropionate aerosol spray
Betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: LP0113 aerosol spray (Drug)
Betamethasone dipropionate aerosol spray
Betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Aerosol spray vehicle (Drug)
Betamethasone dipropionate aerosol spray
Betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: LEO 90100 aerosol foam (Drug)
Betamethasone dipropionate aerosol spray
Betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Calcipotriol aerosol spray (Drug)
Betamethasone dipropionate aerosol spray
Betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Daivobet® gel (Drug)
Calcipotriol aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g, topical
干预措施: LP0113 aerosol spray (Drug)
Calcipotriol aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g, topical
干预措施: Betamethasone dipropionate aerosol spray (Drug)
Calcipotriol aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g, topical
干预措施: Daivobet® gel (Drug)
Daivobet® gel
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: LP0113 aerosol spray (Drug)
Daivobet® gel
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Aerosol spray vehicle (Drug)
Daivobet® gel
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: LEO 90100 aerosol foam (Drug)
Daivobet® gel
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Betamethasone dipropionate aerosol spray (Drug)
Daivobet® gel
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
干预措施: Calcipotriol aerosol spray (Drug)
结局指标
主要结局
Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)
时间窗: End of treatment compared to baseline - 4 weeks
次要结局
- Absolute change in single clinical sign score: erythema, scaling, infiltration(End of treatment and individual visits compared to baseline - 4 weeks)
- Absolute change in total skin thickness and echo-poor band thickness(End of treatment compared to baseline - 4 weeks)
- Absolute Change in Total Clinical Score (TCS)(Individual visits compared to baseline - 4 weeks)