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

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

Tracking Information

• First Submitted Date: April 5, 2021
• First Posted Date: April 13, 2021
• Last Update Posted Date: April 15, 2021
• Actual Study Start Date: April 5, 2021
• Estimated Primary Completion Date: October 4, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 8, 2021)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 Type: Interventional
• Study Phase: Early Phase 1

Study Design

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

• Condition: Androgenetic Alopecia

Intervention

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

Study Arms

• 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.
  Intervention: Drug: Hemp 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.
  Intervention: Drug: Hemp Oil

Publications *

• Baswan SM, Klosner AE, Glynn K, Rajgopal A, Malik K, Yim S, Stern N. Therapeutic Potential of Cannabidiol (CBD) for Skin Health and Disorders. Clin Cosmet Investig Dermatol. 2020 Dec 8;13:927-942. doi: 10.2147/CCID.S286411. eCollection 2020.
• Telek A, Biro T, Bodo E, Toth BI, Borbiro I, Kunos G, Paus R. Inhibition of human hair follicle growth by endo- and exocannabinoids. FASEB J. 2007 Nov;21(13):3534-41. doi: 10.1096/fj.06-7689com. Epub 2007 Jun 12.
• Sugawara K, Zakany N, Tiede S, Purba T, Harries M, Tsuruta D, Biro T, Paus R. Human epithelial stem cell survival within their niche requires "tonic" cannabinoid receptor 1-signalling-Lessons from the hair follicle. Exp Dermatol. 2021 Apr;30(4):479-493. doi: 10.1111/exd.14294. Epub 2021 Feb 26.
• Smith GL, Satino J. Hair Regrowth with Cannabidiol (CBD)-rich Hemp Extract - A Case Series. Cannabis. 2021 Apr 22;4(1):53-59. doi: 10.26828/cannabis/2021.01.003. eCollection 2021.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 8, 2021): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 4, 2021
• Estimated Primary Completion Date: October 4, 2021 (Final data collection date for primary outcome measure)

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.

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04842383
• Other Study ID Numbers: Alopecia Treated with Hemp oil
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Gregory L Smith, MD, MPH, Medical Life Care Planners, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Gregory L Smith, MD, MPH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Medical Life Care Planners, LLC
• Verification Date: April 2021