Clinical trial NCT06129591: Topical CBD Scar Healing Study
Official title: The Effects of Topical Cannabidiol on Paramedian Forehead Flap Scar Healing: A Split Scar Study (TOPSCAR)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Paramedian Forehead Flap
Keywords: CBD oil
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of CBD Oil's Impact on postoperative scars in paramedian forehead flap reconstruction patients.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
Study officials:
References: