Clinical trial NCT05650697: Topical CBD Scar Outcomes Study
Official title: The Effects of Topical Cannabidiol on Paramedian Forehead Flap Scar Healing: A Split Scar Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Forehead; Wound
Keywords: Paramedian forehead flap (PMFF)
cannabidiol (CBD) oil
Split-scar
silicone patch
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This double arm, open label, single-site pilot trial aims to evaluate the feasibility of using topical CBD oil on paramedian forehead scars to determine if there is an improved outcome in the appearance of the scar.
Primary purpose: TREATMENT

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 randomized to which half of the scar the ointment will be applied. Neither they nor their physician will choose which half of the scar will have the experimental ointment applied. Specific instructions will be given to the patient on how to apply each drug (the silicone patch to one segment of the scar and the CBD with silicone patch to the other segment of the scar). They will apply the treatments twice a day for 2 months and, at their follow-up appointments, complete two questionnaires about how the scar is healing. Photographs of the scars will be taken at each visit and will be evaluated to determine if there is an improved outcome in the appearance of the scar.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of subjective and objective effects of CBD on the outcomes of healing scars
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Mark Mims, MD
role: PRINCIPAL_INVESTIGATOR
References: