EUCTR2013-004686-14-FR进行中（未招募）1 期
EO 90100 aerosol foam compared to calcipotriol plus betamethasone dipropionate gel in subjects with psoriasis vulgaris - The PSO-ABLE trial
EO Pharma A/S0 个研究点目标入组 463 人开始时间: 2015年6月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 463
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age 18 years or above
- •2. Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2 to 30% of the Body Surface Area (BSA)
- •3. Physician's Global Assessment of disease severity
- •(PGA) of at least mild on trunk and limbs
- •4. m-PASI score of at least 2 on the trunk and limbs
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- •2. 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)
- •3. 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)
- •4. 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.
- •5. Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation
- •6. Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation
- •7. Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation
- •8. Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation
- •9. Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding
研究者
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