Topical CBD Scar Healing Study

ConditionParamedian Forehead Flap

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients younger than 18 years of age

Non-English speaking patients

Patients with known allergies to CBD

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

22 Participants

are divided into 2 treatment groups

Group A: Split-scar randomized trial arm with CBD oilExperimental treatment 1 intervention

Group B: Split-scar randomized trial arm without CBD oilPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Source ClinicalTrials.gov

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