CBD oil tested for better scar healing in nose reconstruction patients
NCT ID NCT06129591
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This study tests whether applying cannabidiol (CBD) oil along with silicone patches can improve the appearance of scars after paramedian forehead flap surgery—a procedure often used to rebuild the nose. About 22 adults who have had this surgery will use CBD oil on one part of their scar and a placebo on the other, with results tracked over 7 months using a standard scar rating scale. The goal is to see if CBD helps scars heal better and look less noticeable.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States