Status:
NOT_YET_RECRUITING
Topical CBD Scar Healing Study
Lead Sponsor:
University of Oklahoma
Conditions:
Paramedian Forehead Flap
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out what effects (good and bad) that cannabidiol (CBD) has on scar healing and appearance in patients who have undergone paramedian forehead flap reconstruction.
Detailed Description
The patient will be asked to apply a silicone patch to half of the scar and experimental ointment (CBD oil ointment) with silicone patch) to the other half of the scar on their forehead. They will be ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients that are adults (18+) of all genders and ethnicities who have undergone a PMFF (Paramedian forehead flap) will be considered for this study.
- English-speaking patients
- Exclusion Criteria
- Patients younger than 18 years of age
- Non-English speaking patients
- Patients with known allergies to CBD
- Pregnant women
- Prisoners
- Patients with moderate to severe hepatic impairment
- A history of suicidal ideation and behavior within the last 6 months
- Patients with severe depression
- Who anticipate coadministration of other CNS depressants including alcohol that could potentiate the sedating effects of the drug
- Patients with a history of severe hypersensitivity reactions to adhesives
- Patients who anticipate coadministration of potentially hepatotoxic drugs
- Patients who anticipate coadministration of sensitive CYP2C19 substrates per labeling
- Termination criteria
- There will be immediate termination from the study if any allergic response to the CBD/silicone combination occurs or if the topical application of CBD/silicone significantly worsens the scar outcome at the Follow Up 2 visit or at any subsequent visit.
- Subject will not receive any additional CBD doses if they experience an adverse event assessed as ≥ Grade 3 (including hepatotoxicities and hematologic adverse events, ≥ Grade 2 for the system-organ class of Cardiac Disorders) according to CTCAE v5. They will remain on study in follow-up until the adverse event resolves or stabilizes.
- If the patient voluntarily requests cessation in the study.
- Pregnancy
- Increase in serum transaminases (ALT/AST) to above three times the upper limit of normal or increase in total bilirubin to above two times the upper limit of normal.
- If a subject experiences worsening depression or suicidal ideation or behavior, the participant will be discontinued from treatment with CBD and immediately referred to a mental health professional. The decision to resume treatment with CBD will be made in collaboration with a mental health professional.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06129591
Start Date
October 1 2025
End Date
July 1 2027
Last Update
September 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104