NCT05650697

Topical CBD Scar Outcomes Study

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-12-14
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study