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临床试验/NCT04842383
NCT04842383Unknown早期 1 期

Androgenetic Alopecia Treatment Using Varin and Cannabidiol-rich Topical Hemp Oil - A Case Series

Gregory L Smith, MD, MPH1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
40
试验地点
1
主要终点
Change in nonvellus hair count in 1cm2 area of the bald scalp

研究概览

简要总结

This is a case series of adult, male and female subjects with androgenetic alopecia (male pattern baldness). A topical hemp oil that is rich in varins (THCV and CBDV) and cannabidiol (CBD) is being used daily for six months to stimulate hair regrowth using Endocannabinoid System (ECS) receptors that are found on hair follicles.

详细描述

The study is a case series of adults (males and females) presenting to a "Hair and Scalp" center in Clearwater, Florida. Subjects diagnosed with androgenetic alopecia (AGA - male pattern baldness) and who were not currently using minoxidil or finasteride, were offered the opportunity to receive a topical hemp-oil extract that is high in varins (tetrahydrocannabivarin, (THCV) cannabidivarin (CBDV)) as well as cannabidiol (CBD). The topical also contains 3% peppermint oil. The subjects were given the topical free of charge. Subjects were randomly assigned to one of two doses, 500mg of hemp oil per dispenser or 1000mg per dispenser. Each dispenser lasted approximately one month, so they used either 1.7mg or 3.4 mg of hemp extract per day.

Forty subjects withAGA with Norwood-Hamilton Classification score of 3V or higher will be selected randomly. The predefined endpoints were hair counts obtained in a defined, representative area of scalp hair loss using a small tattoo to confirm the location of measuring hair loss. The primary investigator will make a clinical assessment of hair growth.

The subjects gave their written informed consent for this six-month trial. The study adhered to the Helsinki guidelines and was institutionally approved. None of the subjects were currently using minoxidil or finasteride. No other hair loss treatments were used during the six months of the research.

The subjects were randomly assigned to using a dropper bottle or spray can with a nozzle to apply the extract. Subjects are advised to apply a thin layer once each morning to the areas of baldness. The hemp oil extract with peppermint was independently analyzed The hemp oil was infused into a lanolin base lotion and natural Emu oil carrier. Each container (dropper bottle or spray can) contained one ounce of the extract. Each container is expected to last approximately one month. The subjects were advised that they could use blow dryers, conditioners, and other hair preparations. The hemp extract was replaced as needed throughout the six-month trial.

A hair count of the greatest area of alopecia was carried out before treatment was started and again after six months of treatment. To facilitate consistent hair count analysis, a small permanent black tattoo, approximately 1mm in diameter, was applied to each subject's head at the area of greatest alopecia. The nonvellus hairs within the 1 cm2 cutout were pulled through the opening with a surgical skin hook and a hair count was taken using a Bodelin ProScope with 50x magnification.

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, Outcomes Assessor)

盲法说明

The participants in the study and the outcomes assessor on day 0 and day 180 will be prevented from having knowledge of which of the two strengths of cannabinoid topicals were used.

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

  • Age 18 or older
  • Physician-diagnosed androgenetic alopecia (AGA) with Norwood-Hamilton Classification score of 3V or higher.
  • Not currently using minoxidil or finasteride.
  • Agree to complete six months of the study.
  • Agreed to not use other hair loss treatments, including minoxidil and/or finasteride during the six months of the study.
  • Agrees to and signs Informed Consent Form.

排除标准

  • Inability to meet the 'Inclusion Criteria' above.

研究组 & 干预措施

Half strength Hemp Oil Preparation

Active Comparator

The topical preparation contains only 500mg of cannabinoids per ounce. The other ingredients are the same in both arms.

干预措施: Hemp Oil (Drug)

Full strength Hemp Oil Preparation

Active Comparator

The topical preparation contains 1000mg of cannabinoids per ounce. The other ingredients are the same in both arms.

干预措施: Hemp Oil (Drug)

结局指标

主要结局

Change in nonvellus hair count in 1cm2 area of the bald scalp

时间窗: six months

Change in nonvellus hair count in standard area of the bald scalp

次要结局

未报告次要终点

研究者

发起方
Gregory L Smith, MD, MPH
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gregory L Smith, MD, MPH

Primary Investigator

Medical Life Care Planners, LLC

研究点 (1)

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