Topical CBD Scar Outcomes Study

NCT ID: NCT05650697

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-12-31

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.

Conditions

Forehead; Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Group 1 cannabidiol (CBD) with silicone ointment

Intervention Type: BIOLOGICAL

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.

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).

Group Type: ACTIVE_COMPARATOR

Group 2 silicone patch

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Mims, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Central Contacts

Ingrid Block

Role: CONTACT

SCC-IIT-Office@ouhsc.edu

405-271-8777

Lead Nurse

Role: CONTACT

SCC-IIT-Office@ouhsc.edu

405-271-8777

Facility Contacts

Mark Mims, MD

Role: primary

mark-mims@ouhsc.edu

405-271-5504

Other Identifiers

15413

Identifier Type: -

Identifier Source: org_study_id