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NCT05456113 Clinical Trial

Topical Cannabidiol Application and Skin Vascular Reactivity

Effect of Drug Clinical Trial

— cannabidiol  

Official title:
Cannabidiol and Vascular Reactivity to Skin Sensory Nerve Stimulation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05456113
Other study ID # 20515
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 1, 2024
Est. completion date October 1, 2026

Study information
Verified date October 2023
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 48
Est. completion date October 1, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Cannabidiol
Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine

Locations
Country Name City State
United States Noll Laboratory University Park Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cutaneous Vascular Conductance pulse units as measured by laser Doppler flowmetry ~5 hours
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