Topical CBD Scar Healing Study

Phase 1

Not yet recruiting

• Conditions: Paramedian Forehead Flap
• Interventions: Drug: Lazarus Naturals THC-Free CBD Tincture (flavorless) + Silicone patch; Drug: Silicone patch

• Registration Number: NCT06129591
• Lead Sponsor: University of Oklahoma

Brief Summary

CBD has anti-inflammatory properties, and it interacts with skin receptors that help keep the skin healthy. This is why, investigators are looking into using CBD oil on forehead scars to see if it makes scars look better.

Detailed Description

Investigators are planning to evaluate the subjective and objective impact of CBD oil on scar healing outcomes, specifically focusing on postoperative scars resulting from paramedian forehead flap reconstruction. The study will employ a split-scar randomized control trial with established outcome measurement tools. Prospective participants undergoing this procedure will be enrolled, with the vertical forehead scar as the primary area of interest.

Participants will be randomly assigned to one of two groups: the control group, which will receive treatment with a silicone patch only, or the experimental group, which will receive a combination of CBD oil and a silicone patch. The allocation of treatment to the top or bottom vertical half of the scar will be randomized for each patient.

Participants will be monitored for a duration of 6 months, during which they will complete the Modified Patient and Observer Scar Assessment Scale at each postoperative visit. After the 6-month period, a blinded rater will evaluate photographs of the scars using the Scar Cosmesis and Rating Scale, without knowledge of the treatment received.

Study Timeline

• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Study Start: 2024-12
• Primary Completion: 2026-06
• Study Completion: 2027-06

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
Split-scar randomized trial arm with CBD oil	Lazarus Naturals THC-Free CBD Tincture (flavorless) + Silicone patch	The study targets the vertical forehead scar, treating half with CBD oil and a silicone patch (experimental).
Split-scar randomized trial arm without CBD oil	Silicone patch	The study targets the vertical forehead scar, treating half with a silicone patch (control).

Primary Outcome Measures

Name	Time	Method
Proportion of CBD Oil's Impact on postoperative scars in paramedian forehead flap reconstruction patients.	2 years	A proportion of patient will be assessed using 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 6 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 Science Center; 🇺🇸 Oklahoma City, Oklahoma, United States