JPRN-jRCTs041180012已完成4 期
Comparison of efficacy and safety between apremilast with concomitant phototherapy and phototherapy alone in psoriasis vulgaris patients - HOPE
Morita Akimichi0 个研究点目标入组 42 人开始时间: 2018年11月9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
- 42
研究概览
简要总结
We compared the efficacy and safety between the Apremilast+phototherapy combination therapy and the phototherapy. In the therapeutic effect on the improvement rate of PASI scores up to 8 weeks, the therapeutic effect was greater in the Apremilast+phototherapy combination than in the phototherapy. The similar results were achieved for other indicators of therapeutic effect, and we found that the Apremilast+phototherapy combination was significantly higher than the phototherapy in the treatment of psoriasis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1) Subjects diagnosed with moderate or higher psoriasis vulgaris. Subjects with arthrosis psoriasis can be entered
- •2) Subject is male and female,80 > years of age ,20 <= years of age
- •3) Baseline BSA 5% <= or sPGA score 3 <=
- •4) Subjects with insufficient effect by topical therapy for external preparations
排除标准
- •1) Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study
- •2) Subject has a known hypersensitivity to any excipients of Apremilast
- •3) Subject has a known hypersensitivity to any excipients of phototherapy
- •4) Patients diagnosed with psoriasis other than psoriasis vulgaris, arthropathic psoriasis
- •5) Subjects who are known to have insufficient phototherapy
- •6) Subject has concurrent skin malignancy or history of skin malignancy . However, if there is no recurrence for the past 5 years it will be accepted
- •7) Subjects with high carcinogenic risk (patients with pigmentosal xeroderma, arsenic oral contact and contact history, radiation exposure history)
- •8) Subjects with psoriasis recurrence / relapse within 4 weeks before baseline started
- •9) Subjects do not want/avoid long-time sunlight or UV light
- •10) Subjects have been treated with Study drugs
- •11) Subjects have been treated with Chigason within 12 weeks before baseline patient
- •12) Subjects have been treated with biologics agent that is Indications for psoriasis within 12 weeks before baseline patient. However, patients who have been treated with Secukinumab or Risankizumab within 24 weeks prior to the start of treatment are not eligible.
- •13) Subjects have been treated with cyclosporine or methotrexate within 4 weeks before baseline
- •14) Subjects have been irradiated skin with UVA or UVB within 2 weeks before baseline
- •15) Subjects have been treated with Strongest's external steroid within 2 weeks before baseline
- •16) Subject has any other condition which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study.
研究者
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