Topical Cannabidiol Application and Skin Vascular Reactivity | NCT05456113

Studies
Topical Cannabidiol Application and Skin Vascular Reactivity

NCT05456113

Sponsor

Penn State University

Status

Withdrawn

Last Update Posted

Jan 17, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Effect of Drug

Interventions

Cannabidiol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no funding

Expanded Access Info

Start Date

Dec 1, 2024Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Oct 1, 2026Estimated

First Submitted Date

Jul 11, 2022

First Submission Date that Met QC Criteria

Jul 11, 2022

First Posted Date

Jul 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2025

Last Update Posted Date

Jan 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Vehicle control, does not contain cannabidiol	Biological: Cannabidiol
Cannabidiol	Experimental	Active ingredient experimental arm, contains full spectrum connabidiol	Biological: Cannabidiol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cannabidiol	Biological	Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine	Cannabidiol Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Noll Laboratory		University Park	Pennsylvania	16802	United States

Intervention Browse Module

MeSH Terms

ID	Term
D002185	Cannabidiol

Ancestor Terms

ID	Term
D002186	Cannabinoids
D013729	Terpenes
D006838	Hydrocarbons
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided