Topical Cannabidiol Application and Skin Vascular Reactivity (cannabidiol)

Cannabidiol and Vascular Reactivity to Skin Sensory Nerve Stimulation

Cannabidiol, or CBD, is an over-the-counter "nutraceutical" that is more commonly being used by healthy adults for pain management, recovery from strenuous exercise, and general wellness. However, little research exists on the effects of CBD in otherwise healthy individuals. This study uses iontophoresis, a common technique used in physical therapy, to determine the effectiveness of topical CBD in lessening the reflex increased cutaneous vascular conductance response to stimulation of the skin.

Study Overview

• Status: Enrolling by invitation
• Conditions: Effect of Drug
• Intervention / Treatment: Biological: Cannabidiol

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Noll Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women 18 years of age and older
• English speaking
• Non-obese class III, BMI ≤ 39.9
• Normal HbA1C of <6.5%

Exclusion Criteria:

• Abnormal resting heart rate (<60 or >100 bpm) or BP (systolic <100 or >129 mmHg, diastolic <60 or >100 mmHg) values
• Rash, skin disease, disorders of pigmentation
• Known skin allergies
• Diabetes
• Nicotine use (e.g. smoking, chewing tobacco, vaping, etc.)
• Illegal drug use
• Recent (within the last 30 days) CBD users either topical or oral
• Allergy or hypersensitivity to investigational agents
• Women who are pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Vehicle control, does not contain cannabidiol	Biological: Cannabidiol; Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine
Experimental: Cannabidiol; Active ingredient experimental arm, contains full spectrum connabidiol	Biological: Cannabidiol; Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cutaneous Vascular Conductance	pulse units as measured by laser Doppler flowmetry	~5 hours

Collaborators and Investigators

• Sponsor: Penn State University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 20515

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No