Recruiting
Phase 1

Cannabidiol

Sponsor:

University of Oklahoma

Code:

NCT06129591

Conditions

Paramedian Forehead Flap

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vantage Hemp CBD Isolate + Silicone patch

Silicone patch

Study Details

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.

Conditions

Paramedian Forehead Flap

Study ID

NCT06129591

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Split-scar randomized trial arm with CBD oil

The study targets the vertical forehead scar, treating half with CBD oil and a silicone patch (experimental).

placebo comparator: Split-scar randomized trial arm without CBD oil

The study targets the vertical forehead scar, treating the other scar half with a silicone patch (control).

Interventions

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 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.

Primary outcome measure

  • Assessment of subjective and objective effects of CBD on the outcomes of healing scars. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Ingrid Block

405-271-8777SCC-IIT-Office@ouhsc.edu

Lead Nurse

405-271-8777SCC-IIT-Office@ouhsc.edu

Locations

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Mark Mims, M.D., Ph.D.,

405-271-5504Mark-Mims@ouhsc.edu

Principal Investigator:

Mark Mims, M.D., Ph.D.,

More Information

Sponsor

University of Oklahoma

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • CBD oil
  • Paramedian Forehead Flap Reconstruction
  • silicone patch

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-09-01.