University of Oklahoma
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.
Paramedian Forehead Flap
Lazarus Naturals THC-Free CBD Tincture (flavorless) + Silicone patch
Silicone patch
PHASE1
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 Type : | INTERVENTIONAL |
| Estimated Enrollment : | 22 participants |
| Masking : | SINGLE |
| 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) |
| Actual Study Start Date : | 2024-12 |
| Estimated Primary Completion Date : | 2026-06 |
| Estimated Study Completion Date : | 2027-06 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104