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临床试验/NCT06239324
NCT06239324招募中1 期

Evaluation of Latanoprost Combined With Fractional Erbium- YAG Laser Versus Microneedling in Alopecia Areata Treatment

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
70
试验地点
1
主要终点
fractional Erbium YAG laser

研究概览

简要总结

Alopecia areata (AA) an autoimmune disorder of hair follicles results in varying degrees of scalp, facial and body hair loss.

Clinically, patients' presentation varies from patchy circumscribed scalp involvement to total body and scalp hair loss affects up to 2% of the general population.

The exact pathobiology of AA has still remained elusive, while the common theory is the collapse of the immune privilege of the hair follicle caused by immunological mechanism. Multiple genetic, environment factors and psychological stress contribute to the pathogenesis of Alopecia Areata .

Recent insights into the pathogenesis of AA have led to the development of new treatment strategies, such as Janus kinase inhibitors, biologics and several small molecular agents. In addition, modern therapies for AA, including antihistamines, platelet-rich plasma injection

详细描述

Latanoprost is a prostaglandin analogue with well-established efficacy in the treatment of open-angle glaucoma and ocular hypertension.

Make an increase in the number, thickness and length of eyelashes is an important side effect of latanoprost eye drop. This study aimed to evaluate the effect of hypertrichosis property of latanoprost in the treatment of scalp Alopecia Areata.

Numerous techniques and agents such as microneedling, dermabrasion, radiofrequency and lasers have been used to increase penetration within an approach known as transdermal drug delivery.

One of these techniques is laser-assisted drug delivery (LADD), which often uses ablative fractional lasers (CO2 or erbium: YAG lasers) because of their capacity to produce microscopic ablated channels.

LADD is a promising technique that enhances the absorption of topical molecules while adding the synergic effect.

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
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes with localized stable alopecia areata of the scalp of 3 months duration at least.

排除标准

  • Acute or chronic infections.
  • Pregnant or lactating women.
  • Scarring alopecia.
  • Alopecia totalis , Alopecia universalis and ophiasis.
  • Autoimmune dermatological diseases.

研究组 & 干预措施

Fractional Erbium laser Technique (Group A)

Active Comparator

About 35 patients with alopecia areata will Subject to fractional Erbium (Er-YAG) laser (Fotona Xs dynamics,Slovenia) with energy of 600 mj in short pulse mode (MSP) with spot size of 7 mm diameter, frequency of 3 Hz and pixel 3. Latanoprost( xalatan 0.005% ) is applied to the treated area for all participants.

干预措施: Latanoprost (Drug)

Micro needling Technique (Group B)

Active Comparator

About 35 patients with alopecia areata will Subject to micro needling using electronic dermapen device (Dr Pen Derma PenUltima A6) which has a disposable head personalized for each patient and sterilized after each session. the dermapen will penetrate the skin with depth 0.6 mm. It will pass vertically over the affected area in a circular pattern until pinpoint bleeding appears. Latanoprost ( xalatan 0.005% ) is applied to the treated area for all participants.

干预措施: Latanoprost (Drug)

结局指标

主要结局

fractional Erbium YAG laser

时间窗: from baseline to 3 months after the fractional Erbium YAG laser treatment day.

The Number of Participants With Treatment of fractional Erbium YAG laser assisted delivery of latanoprost versus micro needling with trans-epidermal latanoprost delivery to induce hair growth in alopecia areata.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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