跳至主要内容
临床试验/NCT05502952
NCT05502952Unknown不适用

Combined Microneedling and Topical Pentoxifylline Vesrus Intalesional Pentoxifylline in Treatment of Alopecia Areata: Intra-indiviual Comparative Study

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年7月27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
入组人数
50
试验地点
1
主要终点
measuerement of improvement of alopecia areata patches by SALT score

研究概览

简要总结

Alopecia areata (AA) is a common autoimmune disease that targets hair follicles with a prevalence of approximately 0.1% and a lifetime incidence of approximately 1.7%. AA is the third most prevalent nonscarring hair loss disease. Pentoxifylline (PTX) is a non-selective inhibitor of phosphodiesterases, which moderates the intracellular levels of cyclic adenosine monophosphate and cyclic guanosine monophosphate by decreasing their hydrolysis and augmenting cyclic nucleotide-dependent signal transduction which leads to a wide spectrum of effects on the inflammation. PTX has anti inflammatory effects by inhibiting the pro-inflammatory cytokines (eg, IL-1, IL-6, and IL-8).Intralesional therapy has a number of advantages over topical therapy, including a faster and longer duration of action, penetration that is deeper than topical therapy, removal of the need for long-term topical medication, and improved patient compliance.The effect of microneedling for treatment of AA is supposed to stimulate the dermal papilla and stem cells by mechanical trauma and increasing the blood supply to the hair follicles.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • All patients over the age of 18 years of both sex, with a clinical diagnosis of localised AA of two or more AA scalp patches in the same patient.

排除标准

  • Patients who received systemic or topical treatment for A.A in the previous three months prior to the start of the study.
  • Patients who are pregnant or lactating.
  • Patients who have bleeding or coagulation disorders.
  • Patients with autoimmune diseases, liver, or renal diseases were excluded from the study.

研究组 & 干预措施

Alopecia areata

Experimental

干预措施: Pentoxifylline (Drug)

结局指标

主要结局

measuerement of improvement of alopecia areata patches by SALT score

时间窗: 12 month

The clinical response will be evaluated based on the SALT score, the following percentages of scalp hair regrowth are possible: A0 = no change or further loss, A1 = 1%-24% regrowth, A2 = 25%-49% regrowth, A3 = 50%-74% regrowth, A4 = 75%-99% regrowth, and A5 = 100% regrowth.

measuerement of improvement of alopecia areata patches by Trichoscopic signs

时间窗: 12 month

Trichoscopic examination each visit to evaluate the results and record signs of improvement of the disease including (short vellus hairs and terminal hairs) and disappearance of signs of activity(exclamation marks, blackdots)

次要结局

未报告次要终点

研究者

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

Manar Ibrahim Abdelhameed

assistent lecturer at dermatology,venerology and andrology department

Sohag University

研究点 (1)

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