A Phase 1 interventional study of Vantage Hemp CBD Isolate + Silicone patch and Silicone patch in Paramedian Forehead Flap, sponsored by University of Oklahoma. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University of Oklahoma · Phase 1, Interventional, and Treatment
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.
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.
Exclusion Criteria
Termination criteria
The study targets the vertical forehead scar, treating half with CBD oil and a silicone patch (experimental).
Drug: Vantage Hemp CBD Isolate + Silicone patch
The study targets the vertical forehead scar, treating the other scar half with a silicone patch (control).
Drug: 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.
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.
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).
Time frame: 2 years
Plan to share: No
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University of Oklahoma