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
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Effect of Drug

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