Trials / Completed
CompletedNCT07359976
Pharmacokinetic Evaluation of a Natural CBD Extract
Pharmacokinetic Evaluation of a Natural Hemp Extract-based Cosmetic Product After Topical and Oral Application
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Utah · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The present cross-over study investigated whether cannabidiol (CBD) or its metabolites and delta-9-tetrahydrocannabinol (THC) can be detected in the systemic circulation following a single topical application of a natural hemp extract-based cosmetic (NHEC) consisting of CBD and medium chain triglycerides (capric, caprylic triglycerides or medium chain triglycerides (MCT)) derived from coconut oil. Since consumers can consider hemp/CBD oil as a nutritional product or dietary supplement, it can be ingested by consumers. Therefore, we analyzed the concentrations of CBD, THC, and their metabolites in systemic circulation after oral NHEC administration. Additionally, we tested whether a single topical or oral use of the NHEC would lead to detectable levels of THC in the urine samples using Easy@Home THC detection strips. This study has no intent to treat or prevent any diseases or conditions. In this study, volunteer participants were assigned to one of two study groups: Cohort A (oral administration) or Cohort B (topical administration). After completing the study in the first assigned Cohort, participants had a 15-day washout period before beginning the study in the next Cohort.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | CBD extract | The purified CBD extract dissolved in the medium-chain coconut oil was administered by participants topically or orally. |
Timeline
- Start date
- 2021-01-04
- Primary completion
- 2024-11-07
- Completion
- 2025-01-16
- First posted
- 2026-01-22
- Last updated
- 2026-01-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07359976. Inclusion in this directory is not an endorsement.