History of Changes for Study: NCT04842383

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

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			April 8, 2021	None (earliest Version on record)
2			April 12, 2021	Recruitment Status, Study Status and Study Identification

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	Hair Regrowth with Hemp-oil
Brief Title:	Hair Regrowth Using Varin and Cannabidiol Rich Topical Hemp Oil: A Case Series (Hair Regrowth)
Official Title:	Hair Regrowth in Subjects With Androgenetic Alopecia Using Varin and Cannabidiol-rich Topical Hemp Oil - A Case Series
Secondary IDs:

Study Status


Record Verification:	April 2021
Overall Status:	Recruiting
Study Start:	April 5, 2021
Primary Completion:	October 4, 2021 [Anticipated]
Study Completion:	October 4, 2021 [Anticipated]

First Submitted:	April 5, 2021
First Submitted that Met QC Criteria:	April 8, 2021
First Posted:	April 13, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	April 8, 2021
Last Update Posted:	April 13, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	Gregory L Smith, MD, MPH
Responsible Party:	Sponsor-Investigator Investigator: Gregory L Smith, MD, MPH Official Title: Primary Investigator Affiliation: Medical Life Care Planners, LLC
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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.

Conditions


Conditions:	Androgenetic Alopecia
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Early Phase 1
Interventional Study Model:	Parallel Assignment
	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.
Number of Arms:	2
Masking:	Double (Participant, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	40 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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 Names: 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 Names: THCV, tetrahydrocannabivarin, CBDV, cannabidivarin, peppermint oil

Outcome Measures


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

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
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. -

Contacts/Locations


Central Contact Person:	Gregory L Smith, MD Telephone: 8135021251 Email: MedicalMarijuana@Mail.com
Central Contact Backup:	John Satino, BS Telephone: 7274094191 Email: JSatino@gmail.com
Study Officials:	Gregory L Smith, MD Principal Investigator Medical Life Care Planners, LLC
Locations:	United States, Florida
	Hair and Scalp Clinic [Recruiting] Clearwater, Florida, United States, 33762 Contact:Contact: John Satino, BS 727-409-4191 JSatino@gmail.com Contact:Contact: Gregory L Smith, MD 8135021251 MedicalMarijuana@Mail.com

IPDSharing


Plan to Share IPD:	No

References


Citations:	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. PubMed 33335413
	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. PubMed 17567570
	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. PubMed 33523535
	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. PubMed 37287996
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