CBD Effects on Forehead Split Scar Healing

February 26, 2024 updated by: University of Oklahoma

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  1. Patients younger than 18 years of age
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBD oil + Silicone
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
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.
Experimental: Silicone Only
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Patient and Observer Scar Assessment Scale
Time Frame: 6 month postoperative visit is the final timepoint
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
Time Frame: 6 month postoperative visit.
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
Time Frame: 6 month postoperative visit
Analysis of any local tissue reactions from CBD oil
6 month postoperative visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Mark Mims, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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