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

Primary Purpose

Androgenetic Alopecia

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hemp Oil
Sponsored by
Gregory L Smith, MD, MPH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Hair and Scalp ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Half strength Hemp Oil Preparation

Full strength Hemp Oil Preparation

Arm Description

The topical preparation contains only 500mg of cannabinoids per ounce. The other ingredients are the same in both arms.

The topical preparation contains 1000mg of cannabinoids per ounce. The other ingredients are the same in both arms.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 5, 2021
Last Updated
April 12, 2021
Sponsor
Gregory L Smith, MD, MPH
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1. Study Identification

Unique Protocol Identification Number
NCT04842383
Brief Title
Androgenetic Alopecia Treatment Using Varin and Cannabidiol Rich Topical Hemp Oil: A Case Series
Acronym
Hair Regrowth
Official Title
Androgenetic Alopecia Treatment Using Varin and Cannabidiol-rich Topical Hemp Oil - A Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
October 4, 2021 (Anticipated)
Study Completion Date
October 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gregory L Smith, MD, MPH

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Half strength Hemp Oil Preparation
Arm Type
Active Comparator
Arm Description
The topical preparation contains only 500mg of cannabinoids per ounce. The other ingredients are the same in both arms.
Arm Title
Full strength Hemp Oil Preparation
Arm Type
Active Comparator
Arm Description
The topical preparation contains 1000mg of cannabinoids per ounce. The other ingredients are the same in both arms.
Intervention Type
Drug
Intervention Name(s)
Hemp Oil
Other Intervention Name(s)
THCV, tetrahydrocannabivarin, CBDV, cannabidivarin, peppermint oil
Intervention Description
Hemp oil extract rich in varins (THCV and CBDV) as well as cannabidiol (CBD) in combination with 3% peppermint oil extract
Primary Outcome Measure Information:
Title
Change in nonvellus hair count in 1cm2 area of the bald scalp
Description
Change in nonvellus hair count in standard area of the bald scalp
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory L Smith, MD
Phone
8135021251
Email
MedicalMarijuana@Mail.com
First Name & Middle Initial & Last Name or Official Title & Degree
John Satino, BS
Phone
7274094191
Email
JSatino@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory L Smith, MD
Organizational Affiliation
Medical Life Care Planners, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hair and Scalp Clinic
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Satino, BS
Phone
727-409-4191
Email
JSatino@gmail.com
First Name & Middle Initial & Last Name & Degree
Gregory L Smith, MD
Phone
8135021251
Email
MedicalMarijuana@Mail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33335413
Citation
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.
Results Reference
background
PubMed Identifier
17567570
Citation
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.
Results Reference
background
PubMed Identifier
33523535
Citation
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.
Results Reference
background
PubMed Identifier
37287996
Citation
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.
Results Reference
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Androgenetic Alopecia Treatment Using Varin and Cannabidiol Rich Topical Hemp Oil: A Case Series

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