Topical CBD Scar Outcomes Study (TOPSCAR)

University of Oklahoma (OU)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Forehead; Wound

Treatments: Biological: Group 2 silicone patch; Biological: Group 1 cannabidiol (CBD) with silicone ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT05650697

15413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

CBD + Silicone

Experimental group

Description:

Split-scar randomized trial arm with CBD The study targets the vertical forehead scar, treating half with CBD and a silicone patch (experimental).

Treatment:

Biological: Group 1 cannabidiol (CBD) with silicone ointment

Silicone Only

Active Comparator group

Description:

Split-scar randomized trial arm without CBD The study targets the vertical forehead scar, treating the other scar half with a silicone patch (control).

Treatment:

Biological: Group 2 silicone patch