Topical CBD Patch for Healing a Forehead Scar

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase interventional study assigns adults who have had paramedian forehead flap reconstruction to receive a CBD oil ointment with a silicone patch on one half of their scar and a silicone patch alone on the other half, chosen at random. Participants apply the treatments twice daily for two months, then report on scar healing via questionnaires and photos taken at each visit. The primary goal is to observe safety and any signs of improved scar appearance, using within-subject comparison to control for individual healing factors. The study is conducted at the University of Oklahoma Health Sciences Center and is led by the University of Oklahoma as sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Oklahoma Health Sciences Center
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Mark Mims, M.D., Ph.D. — University of Oklahoma
• Study coordinator: Ingrid Block
• Email: SCC-IIT-Office@ouhsc.edu
• Phone: 405-271-8777

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.