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临床试验/CTRI/2024/07/070098
CTRI/2024/07/070098尚未招募4 期

Trichoscopic comparison of 5% minoxidil lotion monotherapy versus its combination with autologous platelet rich plasma therapy in androgenetic alopecia

ERA S LUCKNOW MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月16日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
•To trichoscopically assess and compare the effectiveness of 5% minoxidil alone and its combination with platelet rich plasma therapy.

研究概览

简要总结

A total of 60 patients of androgenetic alopecia visiting dermatology OPD of Era’s Lucknow Medical College and Hospital fulfilling inclusion criteria will be enrolled in our study. Written and informed consent from patients will be taken prior to participation in study. Patients will be randomly divided into two groups  A and B each containing 30  individuals each. History, clinical examination with trichoscopic evaluation and photographic documentation will be done before the start of the treatment and then at each visit (baseline,3weeks,6weeks,9 weeks and 12 weeks) and results will be tabulated in respective tables. In group A- each patient will be advised minoxidil (5%) twice daily application over scalp for 3weeks with follow up at every 3 week. In group B- each patient will be advised minoxidil (5%) twice daily application over scalp for 3 weeks with platelet rich plasma therapy sessions over scalp at every 3 weeks with follow up at every 3week. Under aseptic precautions, around 16ml of peripheral blood will be collected from the median cubital vein and transferred into a sodium citrate vacutainer. The tubes will be  rotated in a centrifuge machine (REMI) at 2,000 revolutions per minute for 6 minutes and the Buffy coat along with the plasma will be collected with the help of a pipette in another test tube. This tube will again be subjected to asecond centrifugation at 4000 revolutions per minute for 10 minutes. The upper layer containing platelet poor plasma will be discarded, and the lower layer of the PRP will be collected in another clean tube. Multiple PRP injections of 0.1 ml will be given at each site in a linear pattern 1 cm apart using the nappage technique.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
Male

入选标准

  • All consenting male patients in the age group of 20–50 years with AGA stage II–VI Norwood-Hamilton classification visiting in dermatology OPD.

排除标准

  • 1.Patients who have taken any form of treatment in past three months.
  • 2.Patient with a history of hypersensitivity to minoxidil.
  • 3.Patient with a history of bleeding disorders, on anticoagulants medications (aspirin, warfarin, heparin) and and with positive viral markers.
  • 4.Patients with active infection at local site, nonpatterned alopecia, keloidal tendency, history of psoriasis, lichen planus and vitiligo.

结局指标

主要结局

•To trichoscopically assess and compare the effectiveness of 5% minoxidil alone and its combination with platelet rich plasma therapy.

时间窗: Baseline,3 Weeks,6 Weeks,9 Weeks,12 Weeks

次要结局

  • •To trichoscopically evaluate the response in patient with 5% minoxidil monotherapy in individuals with AGA.(•To trichoscopically evaluate the synergistic effects of the combined therapy of 5% minoxidil & PRP in individuals with AGA.)

研究者

发起方
ERA S LUCKNOW MEDICAL COLLEGE AND HOSPITAL
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR GOPAL PRASAD PODDAR

Era’s Lucknow Medical College and Hospital

研究点 (1)

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