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

NCT04842383 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: Alopecia Treated with Hemp oil
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

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

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

  six months

Study Arms (2)

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.

Drug: Hemp Oil

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.

Drug: Hemp Oil

Interventions

Hemp Oil DRUG

Hemp oil extract rich in varins (THCV and CBDV) as well as cannabidiol (CBD) in combination with 3% peppermint oil extract

Also known as: THCV, tetrahydrocannabivarin, CBDV, cannabidivarin, peppermint oil

Full strength Hemp Oil Preparation; Half strength Hemp Oil Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Gregory L Smith, MD, MPH: lead

Study Sites (1)

Hair and Scalp Clinic

Clearwater, Florida, 33762, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 33335413 BACKGROUND

• 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.

  PMID: 17567570 BACKGROUND

• 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.

  PMID: 33523535 BACKGROUND

• 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.

  PMID: 37287996 BACKGROUND

MeSH Terms

Conditions

Alopecia

Interventions

hempseed oil; cannabidivarin; peppermint oil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory L Smith, MD

  Medical Life Care Planners, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory L Smith, MD

CONTACT

8135021251; MedicalMarijuana@Mail.com

John Satino, BS

CONTACT

7274094191; JSatino@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 13, 2021
• Study Start: April 5, 2021
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)