JPRN-jRCTs031180049已完成4 期
Investigation of patient satisfaction and efficacy of Dovobet Gel in patients with plaque psoriasis on the body who show poor adherence - INSPADES Study
akagawa Hidemi0 个研究点目标入组 46 人开始时间: 2018年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
研究概览
简要总结
Because of the high level of patient satisfaction with investigational product (Dovobet gel), especially with regard to its convenience and its sustained therapeutic effect, it is effective in improving treatment adherence. Conversely, the high adherence to Dovobet gel is likely to increase its therepeutic effect. Based on these finding, we expected that Dovobet gel might become the mainstay of topical psoriasis treatment for patients with poor adherence.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients with plaque psoriasis on the body (including those with psoriatic arthritis).
- •2) 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).
- •3) Patients with psoriasis affecting <= 30% of their body surface area (BSA).
- •4) Patients with a physician's global assessment (PGA) rating of mild or higher.
- •5) Patients aged >= 20 years old who provide written informed consent to participation in the study.
排除标准
- •1) Women who are pregnant or possibly pregnant, or who wish to become pregnant during the study period.
- •2) Breast-feeding women.
- •3) Patients with known allergy or possible allergy to any component of the investigational product.
- •4) 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.
- •5) Patients with skin ulcers (other than due to Behcet's disease) and those with second or third-degree burns or frostbite.
- •6) Patients who have previously used the investigational product for treatment of lesions on the body.
- •7) 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.
- •8) 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.
- •9) Patients with symptom of severe renal failure, liver dysfunction or cardiac disease.
- •10) Patients with symptom of hypercalcemia.
- •11) Other patients who are considered to be unsuitable for the study by the investigator or subinvestigator.
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