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Androgenetic Alopecia Treatment Using Varin and Cannabidiol Rich Topical Hemp Oil: A Case Series (Hair Regrowth)

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ClinicalTrials.gov Identifier: NCT04842383
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Gregory L Smith, MD, MPH, Medical Life Care Planners, LLC

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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: Hemp Oil Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 40 subjects will be randomly assigned into two treatment groups, 500mg of cannabinoids per ounce and 1000mg of cannabinoids per ounce. The change in hair follicle numbers will be compared statistically between the two groups.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Androgenetic Alopecia Treatment Using Varin and Cannabidiol-rich Topical Hemp Oil - A Case Series
Actual Study Start Date : April 5, 2021
Estimated Primary Completion Date : October 4, 2021
Estimated Study Completion Date : October 4, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Half strength Hemp Oil Preparation
The topical preparation contains only 500mg of cannabinoids per ounce. The other ingredients are the same in both arms.
Drug: Hemp Oil
Hemp oil extract rich in varins (THCV and CBDV) as well as cannabidiol (CBD) in combination with 3% peppermint oil extract
Other Name: THCV, tetrahydrocannabivarin, CBDV, cannabidivarin, peppermint oil

Active Comparator: Full strength Hemp Oil Preparation
The topical preparation contains 1000mg of cannabinoids per ounce. The other ingredients are the same in both arms.
Drug: Hemp Oil
Hemp oil extract rich in varins (THCV and CBDV) as well as cannabidiol (CBD) in combination with 3% peppermint oil extract
Other Name: THCV, tetrahydrocannabivarin, CBDV, cannabidivarin, peppermint oil




Primary Outcome Measures :
  1. Change in nonvellus hair count in 1cm2 area of the bald scalp [ Time Frame: six months ]
    Change in nonvellus hair count in standard area of the bald scalp



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842383


Contacts
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Contact: Gregory L Smith, MD 8135021251 MedicalMarijuana@Mail.com
Contact: John Satino, BS 7274094191 JSatino@gmail.com

Locations
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United States, Florida
Hair and Scalp Clinic Recruiting
Clearwater, Florida, United States, 33762
Contact: John Satino, BS    727-409-4191    JSatino@gmail.com   
Contact: Gregory L Smith, MD    8135021251    MedicalMarijuana@Mail.com   
Sponsors and Collaborators
Gregory L Smith, MD, MPH
Investigators
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Principal Investigator: Gregory L Smith, MD Medical Life Care Planners, LLC
Publications:
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Responsible Party: Gregory L Smith, MD, MPH, Primary Investigator, Medical Life Care Planners, LLC
ClinicalTrials.gov Identifier: NCT04842383    
Other Study ID Numbers: Alopecia Treated with Hemp oil
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Peppermint oil
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics