Topical CBD Scar Outcomes Study (NCT05650697) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Topical CBD Scar Outcomes Study
United States22 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sta…
What they're measuring
1
Assessment of subjective and objective effects of CBD on the outcomes of healing scars