jRCTs031180049已完成不适用
Investigation of patient satisfaction and efficacy of Dovobet Gel in patients with plaque psoriasis on the body who show poor adherence (INSPADES Study)
未提供0 个研究点目标入组 50 人开始时间: 2019年1月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Drug preference of the subjects
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with plaque psoriasis on the body (including those with psoriatic arthritis).
- •Plaque psoriasis patients with poor adherence (< 60%) and no clinical effect during the 4 weeks before the start of study treatment with regard to use of topical drugs other than the investigational product (topical activated vitamin D3, topical steroids, or in-house mixed preparations of them, or topical fixed combination drugs containing topical steroid and activated vitamin D3).
- •Patients with psoriasis affecting <= 30% of their body surface area (BSA).
- •Patients with a physician's global assessment (PGA) rating of "mild" or higher.
- •Patients aged >= 20 years old who provide written informed consent to participation in the study.
排除标准
- •Women who are pregnant or possibly pregnant, or who wish to become pregnant during the study period.
- •Breast-feeding women.
- •Patients with known allergy or possible allergy to any component of the investigational product.
- •Patients with bacterial, fungal, spirochetal, or viral skin infection or parasite infestation (scabies, hair lice, etc.), and patients with any of these diseases that could potentially be aggravated.
- •Patients with skin ulcers (other than due to Behcet's disease) and those with second or third-degree burns or frostbite.
- •Patients who have previously used the investigational product for treatment of lesions on the body.
- •Patients who have received Tigason during the following period before the start of study treatment: within six months before the start of study treatment for men, or within one year before the start of study treatment for women.
- •Patients who have received systemic treatment with the following biological product during each period before the start of study treatment:
- •Adalimumab, Infliximab, Ixekizumab or Guselkumab: within three months before the start of study treatment.
- •Ustekinumab: within four months before the start of study treatment.
- •Secukinumab or Brodalumab: within five months the before the start of study treatment.
- •Patients with symptom of severe renal failure, liver dysfunction or cardiac disease.
- •Patients with symptom of hypercalcemia.
- •Other patients who are considered to be unsuitable for the study by the investigator or subinvestigator.
结局指标
主要结局
Drug preference of the subjects
时间窗: Week 4 and Week 12
Drug preference of the subjects (determined by using the Patient Preference Questionnaire)
Comparison of patient satisfaction (TSQM-9)
时间窗: baseline (Week 0) and Weeks 4 and 12
Comparison of patient satisfaction (TSQM-9) between baseline (Week 0) and Weeks 4 and 12
Comparison of the PGA
时间窗: baseline (Week 0) and Weeks 4 and 12
Comparison of the PGA between baseline (Week 0) and Weeks 4 and 12
次要结局
- per protocol treatment rate(Weeks 4, 8 and 12)
- application time(Weeks 4, 8 and 12)
- PGA(baseline and Week 8)
- mean modified Psoriasis Area and Severity Index (m-PASI) and mean percent change(baseline and Weeks 4, 8 and 12)
- patient satisfaction (TSQM-9)(baseline and Week 8)
- BSA affected by psoriasis(baseline and Weeks 4, 8 and 12)
- pruritus (Itch Numerical Rating Scale: NRS)(baseline and Weeks 4, 8 and 12)
研究者
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