Double-Blind Study Determining the Efficacy of CannaXR in Decreasing UVA Premutagenic and Photoaging Markers

NCT05279495 | Completed DMC FDA Device

• 1 other identifier: CNXR-001D
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Ultraviolet light A (UVA) causes oxidization of guanine to mutagenic 8-Oxoguanine (8-OxoG) and the most frequent and best characterized mutation in mitochondrial DNA (mtDNA), a deletion of 4,977 base pairs, called the "common deletion", a marker of photoaging.

Conditions

Photoaging

Outcome Measures

Primary Outcomes (1)

• Title: Double-Blind Study to measure and compare the Mean Percent Reduction UVA induced premutagenic and photoaging markers 8-oxo-dG and the common deletion in 20 subjects treated with CANNAXR and Vehicle and exposed to 3X their individual MED-UVA

  Determining the Efficacy of topically applied CANNAXR cream vs vehicle cream in decreasing UVA induced Premutagenic and Photoaging markers 8-oxo-dG and the common deletion in 20 subjects exposed to 3X their individual MED-UVA: Comparison of mean percent reduction in UVA induced 8-Oxo-DG and common deletion in CANNAXR and Vehicle treated skin and exposed to 3X MED-UVA

  2 weeks

Study Arms (1)

Loaded CANNAXR

OTHER

In a double-blinded fashion, 250 mg CANNAXR cream and 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks. In a double-blinded fashion, 250 mg CANNAXR cream and 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks.

Device: In a double-blinded fashion, 250 mg CANNAXR cream; Device: Topical VEHICLE cream

Interventions

In a double-blinded fashion, 250 mg CANNAXR cream DEVICE

Determining the Efficacy of topically applied CANNAXR cream in Decreasing UVA Premutagenic and Photoaging markers 8-oxo-dG and the common deletion. 250 mg TOPICAL CBD CANNAXR Cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks

Also known as: TOPICAL CBD CANNAXR Cream

Loaded CANNAXR

Topical VEHICLE cream DEVICE

Determining the Efficacy of topically applied VEHICLE cream in Decreasing UVA Premutagenic and Photoaging markers 8-oxo-dG and the common deletion. 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks

Loaded CANNAXR

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects
• years of age
• Fitzpatrick skin types II and III

You may not qualify if:

• Pregnancy
• Personal history of skin cancer
• History of abnormal photosensitivity
• Tobacco smoker
• History or being exposed to other forms of radiation (other than sunlight)
• Using any drug/medication that might alter the response of skin to UVA irradiation
• Unable to undergo skin biopsies
• History of abnormal scarring
• History of exposure to the treated areas with external beam X-ray or non-solar UV light irradiation

Sponsors & Collaborators

• MINO Labs, LLC: lead

Study Sites (1)

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Related Publications (7)

• Bruls WA, van Weelden H, van der Leun JC. Transmission of UV-radiation through human epidermal layers as a factor influencing the minimal erythema dose. Photochem Photobiol. 1984 Jan;39(1):63-7. doi: 10.1111/j.1751-1097.1984.tb03405.x. No abstract available.

  PMID: 6701210 BACKGROUND

• Wondrak GT, Jacobson MK, Jacobson EL. Endogenous UVA-photosensitizers: mediators of skin photodamage and novel targets for skin photoprotection. Photochem Photobiol Sci. 2006 Feb;5(2):215-37. doi: 10.1039/b504573h. Epub 2005 Aug 19.

  PMID: 16465308 BACKGROUND

• Zhang X, Rosenstein BS, Wang Y, Lebwohl M, Mitchell DM, Wei H. Induction of 8-oxo-7,8-dihydro-2'-deoxyguanosine by ultraviolet radiation in calf thymus DNA and HeLa cells. Photochem Photobiol. 1997 Jan;65(1):119-24. doi: 10.1111/j.1751-1097.1997.tb01886.x.

  PMID: 9066291 BACKGROUND

• 4. Appendix A. HW Lim, H Honigsmann, and JLM Hawk In Photodermatology, 2007. Informa Healthcare USA, INC. 443-445.

  BACKGROUND

• Yarborough A, Zhang YJ, Hsu TM, Santella RM. Immunoperoxidase detection of 8-hydroxydeoxyguanosine in aflatoxin B1-treated rat liver and human oral mucosal cells. Cancer Res. 1996 Feb 15;56(4):683-8.

  PMID: 8630995 BACKGROUND

• Agar NS, Halliday GM, Barnetson RS, Ananthaswamy HN, Wheeler M, Jones AM. The basal layer in human squamous tumors harbors more UVA than UVB fingerprint mutations: a role for UVA in human skin carcinogenesis. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):4954-9. doi: 10.1073/pnas.0401141101. Epub 2004 Mar 23.

  PMID: 15041750 BACKGROUND

• Berneburg M, Gattermann N, Stege H, Grewe M, Vogelsang K, Ruzicka T, Krutmann J. Chronically ultraviolet-exposed human skin shows a higher mutation frequency of mitochondrial DNA as compared to unexposed skin and the hematopoietic system. Photochem Photobiol. 1997 Aug;66(2):271-5. doi: 10.1111/j.1751-1097.1997.tb08654.x.

  PMID: 9277148 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subjects will receive sufficient CANNAXR cream (CANNAXR pods filled with CBD) and VEHICLE cream (cream with empty CANNAXR pods without CBD) in pump containers, marked right or left. Contents of pump containers unknown to subjects and investigators. All 20 subjects are treated with CANNAXR and Vehicle and the exposed to 3X their individual MED-UVA. The masking relates to which hip (right or left) of each individual receives which treatment, CANNAXR or Vehicle. Therefore there is masking of the treatments of all 20 subjects receiving both treatments, considered by clinicaltrial.gov a single arm study.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study Design: Prospective, double-blind, vehicle-controlled pilot study

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: March 15, 2022
• Study Start: January 15, 2023
• Primary Completion: April 1, 2023
• Study Completion: May 15, 2023
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)