The Effects of Topical Cannabidiol on Paramedian Forehead Flap Scar Healing: A Split Scar Study (TOPSCAR)

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.