CBD Effects on Forehead Split Scar Healing

Study Overview
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Brief Summary
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10 adult patients who have undergone nasal reconstructive surgery and had skin from their forehead used to cover this wound will be asked to participate. Treatment will be of the scar on their forehead, using a silicone ointment, on half of the scar, and CBD oil + silicone ointment, on the second half. Pictures will be taken during the treatment of the scar and questionnaires will be completed. Also, doctors will look at the pictures taken during the healing process and grade the healing of the scar areas.

Detailed Description
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This is a perspective study of 10 adult patients who have undergone nasal reconstructive surgery and had a paramedian forehead flaps. Pictures will be taken, during treatment, of the scar. Silicone ointment will be administered on the first half of the scar and cannabidiol (CBD) oil + silicone ointment on the second half. Participants will be asked to complete a questionnaire at their follow-up clinic visits. Additional data will also be collected: Age, BMI, Medical history with specific interest in conditions which may affect wound healing (Diabetes, immunosuppression, etc), Smoking history, Marijuana use history, Type of cancer, Date of initial surgery, Type of surgery, Length of incision, POSAS and SCAR scale outcomes. Doctors will assess the healing of the scar areas, using cropped pictures, but will not know which half is being treated with the CBD oil + silicone ointment. The doctors will use scar assessment scales for this study. This study will require participant to attend clinical visits for 7 months following their surgery.

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

Conditions
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Forehead; Wound

Intervention / Treatment
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* Biological: Group 1 cannabidiol (CBD) oil with silicone ointment
* Biological: Group 2 cannabidiol (CBD) oil with silicone ointment


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 will be considered for this study. Exclusion Criteria: Patients younger than 18 years of age Patients with known allergies to CBD Provide early 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 or if the patient voluntarily requests cessation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Adult participants will consent to treat their forehead wound scar with silicone oil on half of the scar and CBD oil + silicone on the other half. Participants will be randomized as to which ointment they will place on the top half and the other ointment on the bottom half.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBD oil + Silicone<br>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. | Biological: Group 1 cannabidiol (CBD) oil with silicone ointment<br>* CBD oil with silicone ointment will be used on either the top half of a forehead scar. Specific placement instructions will be given to the participant. They will treat the scar the same way for 7 months.<br>|
| Experimental: Silicone Only<br>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. | Biological: Group 2 cannabidiol (CBD) oil with silicone ointment<br>* CBD oil with silicone ointment will be used on either the bottom half of a forehead scar. Specific placement instructions will be given to the participant. They will treat the scar the same way for 7 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Patient and Observer Scar Assessment Scale | Validated measure to evaluate scar outcomes from a patient and clinician standpoint. The clinician portion is scored on 8 domains with a scale of 1-10 with 1 being closer to normal skin and 10 being worsening scar (minimum 8, maximum 80). The patient portion is graded in 7 domains on a scale of 1-10 with 1 being better and 10 being worse (minimum 7, maximum 70). Higher overall scores describe worse scar outcomes. This will be collected at every follow up visit up to the 6 month visit. | 6 month postoperative visit is the final timepoint | 
| Scar Cosmesis and Rating Scale | Validated measure to evaluate scar outcomes based on photographs. Scale is scored on 6 domains with higher scores describing worse scar outcomes (minimum 0, maximum 13). Will be evaluated by blinded raters. | 6 month postoperative visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin side effects | Analysis of any local tissue reactions from CBD oil | 6 month postoperative visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paramedian forehead flap (PMFF), cannabidiol (CBD) oil, Split-scar