CBD Oil-Scar Healing Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Topical Cannabidiol on Paramedian Forehead Flap Scar Healing: A Split Scar Study (TOPSCAR)

Conditions
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Paramedian Forehead Flap

Intervention / Treatment
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* Drug: Lazarus Naturals THC-Free CBD Tincture (flavorless) + Silicone patch
* Drug: Silicone patch


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria Patients younger than 18 years of age Patients with known allergies to CBD 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. ii. If the patient voluntarily requests cessation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double arm, open label, single-site pilot trial aims to evaluate the feasibility of using topical CBD oil on paramedian forehead scars to determine if there is an improved outcome in the appearance of the scar.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Split-scar randomized trial arm with CBD oil<br>The study targets the vertical forehead scar, treating half with CBD oil and a silicone patch (experimental). | Drug: Lazarus Naturals THC-Free CBD Tincture (flavorless) + Silicone patch<br>* 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. Assessment will be done over a period of 6 months using the Modified Patient and Observer Scar Assessment Scale, followed by blinded photo evaluations using the Scar Cosmesis and Rating Scale. Statistical analysis will assess whether CBD oil improves short-term and long-term scar appearances.<br>|
| Placebo Comparator: Split-scar randomized trial arm without CBD oil<br>The study targets the vertical forehead scar, treating half with a silicone patch (control). | Drug: Silicone patch<br>* A non-treatment group is included in this study to comply with the standard of care, as to treat post-operative wounds with silicone patches to improve final scar outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of CBD Oil's Impact on postoperative scars in paramedian forehead flap reconstruction patients. | 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). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBD oil