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临床试验/CTRI/2024/02/062983
CTRI/2024/02/062983招募中2/3 期

Efficacy of combination of Skin Micro-incision, Pressure Wave Stimulation, Electrostimulation and Photostimulation in the treatment of Pattern hair Loss

Karthik raja1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2024年2月28日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
87
试验地点
1
主要终点
No of new hair follicles in 1 sq cm area

研究概览

简要总结

This is a hospital based uncontrolled trial. Patients with AGA or FPHL will first be examined after getting relevant consent. Photographs will be taken of the front, vertex, lateral and back of the scalp. The severity will then be assessed by Hamilton-Norwood scale for AGA and Ludwig scale for FPHL. Hair pull test will be done and hair count, density, thickness and colour will be noted. Patient will then be subjected to the study device. The guide has been trained in Italy on the proper usage of the device and will train the principal investigator regarding the same. The device consists of 2 probes. The first probe will deliver pressure and micro-incisions by tapping. The micro-incisions are upto a depth of 0.25mm, which will not penetrate into the dermis. This is followed by electric stimulation with activation time of 300 micro seconds and a frequency of 2Hz, which will be delivered by another probe. This probe also simultaneously provides photostimulation at a wavelength of 632nm (Red). Pain experienced during the procedure will be graded using Numerical Rating Scale (NRS). Other side effects, if any, will be noted. The sessions will be repeated once every 3 weeks for a total of 4 sessions. Following 4 sessions, improvement in patient satisfaction, grade, hair pull, count, density, thickness and colour will be assessed. Photographs will be taken as above and compared. Analysis will be done using SPSS Software 21.0.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 25 to 45, suffering from pattern hair loss, which includes Androgenetic Alopecia(AGA) and Female Pattern hair Loss(FPHL).

排除标准

  • Patients with scarring alopecia Patients with other non-scarring alopecias Patients with relevant co-morbidities (Anemia, Thrombocytopenia, Hypo-Hyperthyroidism, Vitamin B D deficiency) Patients on other treatment for AGA,FPHL.

结局指标

主要结局

No of new hair follicles in 1 sq cm area

时间窗: Before study, after 1 month of completion of 4th session

次要结局

  • No of terminal hairs in 1 sq cms area(Before study, after 1 month of completion of 4th session)
  • Hair Color(Before study, after 1 month of completion of 4th session)

研究者

发起方
Karthik raja
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Arun Kumar Jacob R

Sri Muthukumaran Medical College and reserarch institute

研究点 (1)

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