Androgenetic Alopecia Treatment Using Varin and Cannabidiol Rich Topical Hemp Oil: A Case Series

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Brief Title

Androgenetic Alopecia Treatment Using Varin and Cannabidiol Rich Topical Hemp Oil: A Case Series

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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.

      Statistical analysis was done comparing the number of nonvellus hairs in the 1cm2 cutout
      before and after six months of treatment.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

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


Condition

Androgenetic Alopecia

Intervention

Hemp Oil

Study Arms / Comparison Groups

 Half strength Hemp Oil Preparation
Description:  The topical preparation contains only 500mg of cannabinoids per ounce. The other ingredients are the same in both arms.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

April 5, 2021

Completion Date

October 4, 2021

Primary Completion Date

October 4, 2021

Eligibility Criteria

        Inclusion Criteria:

        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.

        Exclusion Criteria:

        Inability to meet the 'Inclusion Criteria' above.

        -
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Gregory L Smith, MD, 8135021251, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04842383

Organization ID

Alopecia Treated with Hemp oil


Responsible Party

Sponsor-Investigator

Study Sponsor

Gregory L Smith, MD, MPH


Study Sponsor

Gregory L Smith, MD, Principal Investigator, Medical Life Care Planners, LLC


Verification Date

April 2021