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Double-Blind Study Determining the Efficacy of CannaXR in Decreasing UVA Premutagenic and Photoaging Markers (CNXR-001D)

Primary Purpose

Photoaging

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In a double-blinded fashion, 250 mg CANNAXR cream
Topical VEHICLE cream
Sponsored by
MINO Labs, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Photoaging

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Population:

Inclusion criteria:

  • Healthy subjects
  • 22-65 years of age
  • Fitzpatrick skin types II and III

Exclusion criteria:

  • 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

Sites / Locations

  • Center for Clinical and Cosmetic Research

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Loaded CANNAXR

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 5, 2022
Last Updated
October 17, 2023
Sponsor
MINO Labs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05279495
Brief Title
Double-Blind Study Determining the Efficacy of CannaXR in Decreasing UVA Premutagenic and Photoaging Markers
Acronym
CNXR-001D
Official Title
Double-Blind Study Determining the Efficacy of CannaXR in Decreasing UVA Premutagenic and Photoaging Markers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MINO Labs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Evaluations & Schedule: Clinical phase: The study of each subject will last 4-5 weeks, with 7 visits (Screening visit 1, Baseline visit 2, Follow up visit 3, Follow up visit 4, Follow up visit 5 and Follow up/Final Visit 6). Screening Visit: Subjects will read and be explained the informed consent. Subjects who agree to participate will sign the informed consent and a copy will be given to them. Exclusion/inclusion criteria will be reviewed. Subjects will be informed that the left arm will be photographed at visits 1 and 3 and both hip/buttock areas at each visit. A urine pregnancy test will be done on baseline (Visit 1, day 0) and final visit 6. Visit 2, Baseline (day 0): Baseline visit will be done no more than 21 days after the screening visit and may be done on the same day as the screening visit. Each subject will be instructed not to change any of his/her photoprotection practices during the duration of the study, including time spent outdoors each weekday and weekend day, with special attention between the hours of 10 AM and 4PM, and sunscreen use and parts of their body where they apply it. The subject's left volar forearm will be exposed to 10, 15, 20, 25, 30, and 35 J/cm2 doses of ultraviolet A light, through a UVA opaque fenestrated adhesive patch placed, 2 cm distally from antecubital fossa. Appropriate UVA opaque shields will be used to protect surrounding untreated areas. In double-blinded fashion, subjects will receive sufficient CANNAXR (extended release) cream (CANNAXR pods filled with CBD) and VEHICLE cream (cream with empty CANNAXR pods without CBD) in pump containers, marked right or left, with detailed application instructions and a template for each cream to be applied to specified 50 cm2 areas of either the left and right, hip/buttock skin daily in the morning and evening for 2 weeks, starting the next morning. Visit 3 (Day 1): MED-A (minimal erythema dose for UVA) will be determined by evaluating skin exposed the prior day to the different UVA doses. MED-A will be defined as the dose that produced "just perceptible erythema". Visit 4 (Day 14) Subjects will be asked about adverse events (predicted or unpredicted, local or systemic) since the last visit. Within the treated areas of the right and left hip/buttock, skin will be treated through fenestrated adhesive UVA-opaque patches as follows: Window #1- no UVA dose, and Window #2 - 3x the subjects UVA-MED (determined on Day 1). Visit 5 (Day 15): Subjects will be asked about adverse events (predicted or unpredicted, local or systemic) since the last visit. Local anesthesia (lidocaine 2% with epinephrine) will be injected and a 4mm punch biopsy will be performed of the skin of each hip/buttock within the templated Windows #1 and #2, as well as at a site 10 cm from the treated area of the left hip/buttock. One or two 5-0 sutures will be placed to appose the skin edges at each of the biopsied sites. Skin biopsy specimens will be divided in half and placed in labelled containers containing appropriate media for 8-oxo-dG (8-oxo deoxyguanosine), common deletion, histochemical and immunochemical studies. Specimens will be shipped to Dr. Adam Friedman for analyses. Supplies and wound care instructions will be given. Visit 6, Final (Day 22-30): Subjects will be asked about adverse events (predicted or unpredicted, local or systemic) since the last visit and all sutures placed at Visit 5 will be removed. A urine pregnancy test will be done. Notes: If an erythematous response after UVA light exposure is symptomatic (burning and tenderness), subjects will be allowed to use twice a day hydrocortisone 1%, over the counter cream, to treat the area. We will provide the cream at the office. Visit 3 has to occur 20-28 hours after baseline visit 2. Visit 5 has to occur 20-28 hours after Visit 4.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Study Design: Prospective, double-blind, vehicle-controlled pilot study
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loaded CANNAXR
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
In a double-blinded fashion, 250 mg CANNAXR cream
Other Intervention Name(s)
TOPICAL CBD CANNAXR Cream
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Topical VEHICLE cream
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Population: Inclusion criteria: Healthy subjects 22-65 years of age Fitzpatrick skin types II and III Exclusion criteria: 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
Facility Information:
Facility Name
Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6701210
Citation
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.
Results Reference
background
PubMed Identifier
16465308
Citation
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.
Results Reference
background
PubMed Identifier
9066291
Citation
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.
Results Reference
background
Citation
4. Appendix A. HW Lim, H Honigsmann, and JLM Hawk In Photodermatology, 2007. Informa Healthcare USA, INC. 443-445.
Results Reference
background
PubMed Identifier
8630995
Citation
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.
Results Reference
background
PubMed Identifier
15041750
Citation
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.
Results Reference
background
PubMed Identifier
9277148
Citation
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.
Results Reference
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Double-Blind Study Determining the Efficacy of CannaXR in Decreasing UVA Premutagenic and Photoaging Markers

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