跳至主要内容
临床试验/CTRI/2023/08/056292
CTRI/2023/08/056292招募中Phase 3 4

To study the efficacy and safety of injectable platelet rich fibrin in androgenetic alopecia- An interventional study

Dr Sahana N C1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年8月16日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
Trichoscopic improvement/ maintenance in the hair density / diameter

研究概览

简要总结

Androgenetic alopecia (AGA), also known as male or female pattern hair loss, is one of the most common chronic progressive hair loss. It’s an androgen dependent and genetically mediated disorder affecting 50% of the population.

In AGA there is progressive involvement of frontal, temporal, midscalp and vertex region

in males and incomplete involvement of these regions with preservance of frontal hairline in females. AGA is a significant stressor and a major cause of low self-esteem and depression.

The utility of platelet-rich plasma (PRP) has spanned various fields of dermatology.

Injectable-PRF is considered the third generation of platelet concentrates possessing a higher and longer release of a variety of growth factors, cytokines and a delicate three-dimensional scaffold structure. It’s developed by modifying spin centrifugation forces based on low speed centrifugation concept (LSCC).5

PRF induces differentiation of stem cells, prolongs survival of dermal papillary cells, prolongs the anagen phase of the hair cycle, increases perifollicular vascular plexus by multiple mechanisms through various growth factors. i-PRF is a simple, less time consuming, cost effective method which need further evaluation in androgenetic alopecia.

METHODOLOGY

After obtaining approval and clearance from the institutional ethics committee, the patients with androgenetic alopecia fulfilling the inclusion criteria and willing to give informed consent will be enrolled in the study.

Details regarding the symptoms, duration, site, family history, precipitating factor and previous treatments if any will be recorded. Global photography of scalp will be taken before and after the treatment and at the end of follow- up period. Trichoscopy will be done in an area of 1 cm2 marked. A metric tape measure graduated in centimeters will be used to mark the square centimeter and the longitudinal distance from the corresponding end of the eyebrow or nasal root. The image of the area will then be amplified using a trichoscope and photographs will be taken before each injection.

10-40 ml of blood will be collected and filled in plain vacutainer tubes (without an anti-coagulant) of 5 ml each and will be centrifuged immediately at 700 rotations per minute for 3 minutes using a REMI-R8C centrifuge machine.

The i-PRF (yellow-reddish liquid) formed at the upper part of the tube will be collected using 31G insulin syringes and injected at a distance of 1cm each entering a depth of 2-4 mm on the entire scalp.

All patients will be on a background therapy of 5% minoxidil solution, oral finasteride 1 mg per day and multivitamin supplements.

Four sitting at 2 weekly intervals will be done and patient will be followed up for 3 months.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to give informed consent
  • Patients of either gender aged 18 to 60 years.
  • Androgenetic Alopecia in males with Norwood-Hamilton grade 2-6 and females beyond grade 1 according to Ludwig’s scale.
  • Patients willing for follow up.

排除标准

  • patients with Alopecia other than Androgenetic Alopecia
  • Patients with active infection at the local site
  • Patients with keloidal tendency
  • Patients with blood coagulopathies and platelets count below 1,50,000cell/mm3
  • Pregnant and lactating mothers.

结局指标

主要结局

Trichoscopic improvement/ maintenance in the hair density / diameter

时间窗: 4 sessions at 2 weekly intervals | Final assessment at the end of 3 months

次要结局

  • Improvements in visual analogue scale(Improvements in global photography)

研究者

发起方
Dr Sahana N C
申办方类型
Other [Self ]

研究点 (1)

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