LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in 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
- 504
- 试验地点
- 1
- 主要终点
- Treatment Success According to the PGA
研究概览
简要总结
The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in 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
- 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
- •Age 18 years or above
- •Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
- •A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and limbs
- •A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk and limbs.
排除标准
- •Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- •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
- •adalimumab, infliximab - within 8 weeks prior to randomisation
- •ustekinumab - within 16 weeks prior to randomisation
- •other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer)
- •Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants within 4 weeks prior to randomisation)
- •Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
- •Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation
- •Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation
- •Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation
- •Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation
- •Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding
研究组 & 干预措施
LEO 90100
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
干预措施: LEO 90100 aerosol foam (Drug)
Aerosol foam vehicle
Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
干预措施: Aerosol foam vehicle (Drug)
Calcipotriol BDP gel
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
干预措施: Calcipotriol BDP gel (Drug)
Gel vehicle
Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
干预措施: Gel vehicle (Drug)
结局指标
主要结局
Treatment Success According to the PGA
时间窗: 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel
To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris. Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA). 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.
次要结局
- Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).(Baseline to Week 4)
- Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).(Baseline to Week 4; Baseline to Week 8)
- Time to 'Treatment Success' According to PGA.(From Baseline to Week 12)
- Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.(Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel)