CBD Oil-Scar Healing Study

Sponsor

University of Oklahoma (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06129591

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Paramedian Forehead Flap	Drug: Lazarus Naturals THC-Free CBD Tincture (flavorless) + Silicone patch Drug: Silicone patch	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Outcomes Assessor)

Masking Description:

The patient will know which part of the scar receives the silicone patch or silicone patch plus CBD because CBD requires separate oil application before the patch. However, the reviewing physicians will be blinded when assessing post-operative photos and using the SCAR scale.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Split-scar randomized trial arm with CBD oil 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 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.
Placebo Comparator: Split-scar randomized trial arm without CBD oil The study targets the vertical forehead scar, treating half with a silicone patch (control).	Drug: Silicone patch 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.

Arm

Intervention/Treatment

Experimental: Split-scar randomized trial arm with CBD oil

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

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.

Placebo Comparator: Split-scar randomized trial arm without CBD oil

The study targets the vertical forehead scar, treating half with a silicone patch (control).

Drug: Silicone patch

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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

University of Oklahoma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Oklahoma

ClinicalTrials.gov Identifier:

NCT06129591

Other Study ID Numbers:

OU-SCC-TOPSCAR

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Oklahoma

CBD oil

Study Results

No Results Posted as of Nov 13, 2023