Topical CBD Scar Healing Study

University of Oklahoma (OU)

Status and phase: Not yet enrolling; Phase 1

Conditions: Paramedian Forehead Flap

Treatments: Drug: Silicone patch; Drug: Lazarus Naturals THC-Free CBD Tincture (flavorless) + Silicone patch

Study type: Interventional

Funder types: Other

Identifiers

NCT06129591

OU-SCC-TOPSCAR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups, including a placebo group

Split-scar randomized trial arm with CBD oil

Experimental group

Description:

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

Treatment:

Drug: Lazarus Naturals THC-Free CBD Tincture (flavorless) + Silicone patch

Split-scar randomized trial arm without CBD oil

Placebo Comparator group

Description:

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

Treatment:

Drug: Silicone patch