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临床试验/NCT07816575
NCT07816575已完成不适用

Comparative Efficacy of Alpha Hydroxy Acids With and Without Nanocarriers Versus Calcipotriol Plus Betamethasone in Treatment of Plaque Psoriasis

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Percentage Change in PASI Score.

研究概览

简要总结

The aim of this double blind comparative clinical study is to evaluate the efficacy of AHAs combined with nanocarriers and their use as a non steroidal alternative drug for long term management of plaque psoriasis

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mid to moderate cases according to Psoriasis Area and Severity Index (PASI).
  • Age from18-65 years old.
  • Denovo psoriatic patients and patients with no psoriasis therapy in the previous two months.

排除标准

  • Severe irritation and highly inflamed skin.
  • Pregnant and lactating females.
  • Patients with acute renal insufficiency.
  • Face, flexural and groin lesions.

研究组 & 干预措施

Alpha Hydroxy Acids with Nanocarriers Group

Experimental

Patients received Alpha Hydroxy Acids formulated with nanocarriers.

干预措施: Alpha Hydroxy Acids with nanocarriers (Drug)

Alpha Hydroxy Acids Group.

Experimental

Patients received Alpha Hydroxy Acids only.

干预措施: Alpha Hydroxy Acids only. (Drug)

Placebo Group

Placebo Comparator

Patients received placebo comparator.

干预措施: Placebo. (Other)

Calcipotriol plus betamethasone Group.

Active Comparator

Patients received calcipotriol plus betamethasone.

干预措施: Calcipotriol plus betamethasone (Drug)

结局指标

主要结局

Percentage Change in PASI Score.

时间窗: Baseline and 8 weeks

Reduction in PASI score from baseline to week 8.

次要结局

  • Dermatology Life Quality Index (DLQI)(Baseline and 8 weeks).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bodour Kamal Elshenawy

Resident

Al-Azhar University

研究点 (1)

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