Topical CBD Scar Outcomes Study (TOPSCAR)

The Effects of Topical Cannabidiol on Paramedian Forehead Flap Scar Healing: A Split Scar Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Forehead; Wound
• Intervention / Treatment: Biological: Group 1 cannabidiol (CBD) with silicone ointment; Biological: Group 2 silicone patch

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.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ingrid Block; Phone Number: 405-271-8777; Email: SCC-IIT-Office@ouhsc.edu
• Study Contact Backup: Name: Lead Nurse; Phone Number: 405-271-8777; Email: SCC-IIT-Office@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
      • Contact: Mark Mims, MD; Phone Number: 405-271-5504; Email: mark-mims@ouhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBD + Silicone; Split-scar randomized trial arm with CBD The study targets the vertical forehead scar, treating half with CBD and a silicone patch (experimental).	Biological: Group 1 cannabidiol (CBD) with silicone ointment; Vantage Hemp CBD Isolate + Silicone patch The study intervention is prospective in nature. This "split scar" study directly compares two parts of the healing scar during clinic visits. Photos will be taken at each visit to track progress. Assessments will be done over a period of around 7 months using the Modified Patient and Observer Scar Assessment Scale, followed by blinded photo evaluations using the Scar Cosmesis and Rating Scale.
Active Comparator: Silicone Only; Split-scar randomized trial arm without CBD The study targets the vertical forehead scar, treating the other scar half with a silicone patch (control).	Biological: Group 2 silicone patch; Silicone patch Standard of care silicone patch will be used as the control part of the split scar study. This "split scar" study directly compares two parts of the healing scar during clinic visits. Photos will be taken at each visit to track progress. Assessments will be done over a period of around 7 months using the Modified Patient and Observer Scar Assessment Scale, followed by blinded photo evaluations using the Scar Cosmesis and Rating Scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of subjective and objective effects of CBD on the outcomes of healing scars	Proportion of patients who have a positive effect using CBD oil in combination with the silicone patch. This will be assessed using the Scar Cosmesis Assessment and Rating (SCAR) scale to determine the impact of CBD oil and silicon patch combo. This photographic evaluation of scare will be done over a period of around 7 months to evaluate the scar outcomes, using the scoring system with minimum score of 0 (being best possible outcome) and maximum score of 13 (worst possible scar outcome).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin side effects	Analysis of any local tissue reactions from CBD oil	6 month postoperative visit

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Mark Mims, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Paramedian forehead flap (PMFF); cannabidiol (CBD) oil; Split-scar; silicone patch
• Additional Relevant MeSH Terms: Cone Dystrophy; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Eye Diseases, Hereditary; Vision Disorders; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Wounds and Injuries; Color Vision Defects; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 15413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No