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NOT YET RECRUITING

NCT05650697

EARLY_PHASE1

Topical CBD Scar Outcomes Study

Sponsor: University of Oklahoma

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09

Completion Date

2027-12

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Forehead; Wound

Interventions

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.

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.

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.

Locations (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States