NCT01007591已完成3 期
Calcipotriol Plus Hydrocortisone in Paediatric Patients (Aged 6 to 17 Years) With Psoriasis Vulgaris on the Face and on the Intertriginous Areas
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment
研究概览
简要总结
An international, multi-centre, prospective, randomised, double-blind, active-controlled, 2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17 years) with psoriasis vulgaris on the face and on the intertriginous areas
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of psoriasis vulgaris involving the face
- •Clinical signs of psoriasis vulgaris on the trunk and/or on the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or limbs. The extent and severity of psoriasis vulgaris on trunk and/or limbs should be amenable to topical therapy with any of the allowed medications
- •An extent of psoriatic involvement of the face of at least 5 cm2 (the sum of all facial lesions)
- •Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 30 g (6 to 11 years) or 45 g (12 to 17 years) of ointment per week
- •Disease severity graded as mild, moderate or severe according to the investigator's global assessment of disease severity of the face
- •Aged 6 to 17 years
排除标准
- •Systemic treatment with therapies other than biologicals with a potential effect on psoriasis vulgaris within the 4-week period prior to randomisation
- •Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
- •PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
- •UVB therapy within the 2-week period prior to randomisation
- •Topical treatment of psoriasis vulgaris lesions on the face or on the intertriginous areas within the 2-week period prior to randomisation
- •Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
- •Initiation of or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the treatment phase of the study
- •Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
研究组 & 干预措施
LEO 80190 ointment
Active Comparator
干预措施: LEO 80190 (Drug)
Hydrocortisone 10 mg/g ointment
Active Comparator
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment
时间窗: From baseline (Day 0) to end of treatment (Week 8)
PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula: 0.05 (R+T+S) E It ranged from 0 to 3.6.
次要结局
- Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF(At end of treatment (Week 8))
- The Percentage Change in PASI of the Face LOCF at Week 4(From baseline (Day 0) to Week 4 (Day 28))
- Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF(At end of treatment (Week 8))
- The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF(From baseline (Day 0) to end of treatment (Week 8))
研究者
研究点 (1)
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