Topical CBD Scar Healing Study

NCT06129591 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: OU-SCC-TOPSCAR
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out what effects (good and bad) that cannabidiol (CBD) has on scar healing and appearance in patients who have undergone paramedian forehead flap reconstruction.

Conditions

Paramedian Forehead Flap

Keywords

CBD oil; Paramedian Forehead Flap Reconstruction; silicone patch

Outcome Measures

Primary Outcomes (1)

• Assessment of subjective and objective effects of CBD on the outcomes of healing scars.

  Proportion of patients who have a positive effect using CBD oil in combination with the silicone patch. This will be assessed using the 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 around 7 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

Study Arms (2)

Split-scar randomized trial arm with CBD oil

EXPERIMENTAL

The study targets the vertical forehead scar, treating half with CBD oil and a silicone patch (experimental).

Drug: Vantage Hemp CBD Isolate + Silicone patch

Split-scar randomized trial arm without CBD oil

PLACEBO COMPARATOR

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

Drug: Silicone patch

Interventions

Vantage Hemp CBD Isolate + Silicone patch DRUG

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. Assessments will be done over a period of around 7 months using the Modified Patient and Observer Scar Assessment Scale, followed by blinded photo evaluations using the Scar Cosmesis and Rating Scale.

Split-scar randomized trial arm with CBD oil

Silicone patch DRUG

Standard of care silicone patch will be used as the control part of the split scar study. 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. Assessments will be done over a period of around 7 months using the Modified Patient and Observer Scar Assessment Scale, followed by blinded photo evaluations using the Scar Cosmesis and Rating Scale.

Split-scar randomized trial arm without CBD oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that are adults (18+) of all genders and ethnicities who have undergone a PMFF (Paramedian forehead flap) will be considered for this study.
• English-speaking patients

You may not qualify if:

• Patients younger than 18 years of age
• Non-English speaking patients
• Patients with known allergies to CBD
• Pregnant women
• Prisoners
• Patients with moderate to severe hepatic impairment
• A history of suicidal ideation and behavior within the last 6 months
• Patients with severe depression
• Who anticipate coadministration of other CNS depressants including alcohol that could potentiate the sedating effects of the drug
• Patients with a history of severe hypersensitivity reactions to adhesives
• Patients who anticipate coadministration of potentially hepatotoxic drugs
• Patients who anticipate coadministration of sensitive CYP2C19 substrates per labeling
• 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.
• Subject will not receive any additional CBD doses if they experience an adverse event assessed as ≥ Grade 3 (including hepatotoxicities and hematologic adverse events, ≥ Grade 2 for the system-organ class of Cardiac Disorders) according to CTCAE v5. They will remain on study in follow-up until the adverse event resolves or stabilizes.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Study Officials

• Mark Mims, M.D., Ph.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid Block

CONTACT

405-271-8777; SCC-IIT-Office@ouhsc.edu

Lead Nurse

CONTACT

405-271-8777; SCC-IIT-Office@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This 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.

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 13, 2023
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)