Topical CBD Scar Outcomes Study

Early Phase 1

Not yet recruiting

• Conditions: Forehead; Wound
• Interventions: Biological: Group 2 cannabidiol (CBD) oil with silicone ointment; Biological: Group 1 cannabidiol (CBD) oil with silicone ointment; Biological: Group 1 cannabidiol (CBD) with silicone ointment; Biological: Group 2 silicone patch

• Registration Number: NCT05650697
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-04
• Study Start: 2025-05
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silicone Only	Group 2 cannabidiol (CBD) oil with silicone ointment	These participants will treat the one half of their forehead scar with silicone ointment only. They will attend clinic visits over the course of 7 months, have pictures taken of the scar's healing progress and complete a questionnaire at each visit.
CBD oil + Silicone	Group 1 cannabidiol (CBD) oil with silicone ointment	These participants will treat the one half of their forehead scar with a combination of silicone ointment and cannabidiol (CBD) oil + silicone ointment . They will attend clinic visits over the course of 7 months, have pictures taken of the scar's healing progress and complete a questionnaire at each visit.
CBD + Silicone	Group 1 cannabidiol (CBD) with silicone ointment	Split-scar randomized trial arm with CBD The study targets the vertical forehead scar, treating half with CBD and a silicone patch (experimental).
Silicone Only	Group 2 silicone patch	Split-scar randomized trial arm without CBD The study targets the vertical forehead scar, treating the other scar half with a silicone patch (control).

Primary Outcome Measures

Name	Time	Method
Assessment of subjective and objective effects of CBD on the outcomes of healing scars	2 years	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).

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States