The Effects of Topical Cannabidiol on Paramedian Forehead Flap Scar Healing: A Split Scar Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Assessment of subjective and objective effects of CBD on the outcomes of healing scars
研究概览
简要总结
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.
详细描述
The patient will be asked to apply a silicone patch to half of the scar and experimental ointment (CBD oil ointment) with silicone patch) to the other half of the scar on their forehead. They will be randomized to which half of the scar the ointment will be applied. Neither they nor their physician will choose which half of the scar will have the experimental ointment applied. Specific instructions will be given to the patient on how to apply each drug (the silicone patch to one segment of the scar and the CBD with silicone patch to the other segment of the scar). They will apply the treatments twice a day for 2 months and, at their follow-up appointments, complete two questionnaires about how the scar is healing. Photographs of the scars will be taken at each visit and will be evaluated to determine if there is an improved outcome in the appearance of the scar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 v
- •They will remain on study in follow-up until the adverse event resolves or stabilizes.
- •If the patient voluntarily requests cessation in the study.
- •Pregnancy
- •Increase in serum transaminases (ALT/AST) to above three times the upper limit of normal or increase in total bilirubin to above two times the upper limit of normal.
- •If a subject experiences worsening depression or suicidal ideation or behavior, the participant will be discontinued from treatment with CBD and immediately referred to a mental health professional. The decision to resume treatment with CBD will be made in collaboration with a mental health professional.
研究组 & 干预措施
CBD + Silicone
Split-scar randomized trial arm with CBD The study targets the vertical forehead scar, treating half with CBD and a silicone patch (experimental).
干预措施: Group 1 cannabidiol (CBD) with silicone ointment (Biological)
Silicone Only
Split-scar randomized trial arm without CBD The study targets the vertical forehead scar, treating the other scar half with a silicone patch (control).
干预措施: Group 2 silicone patch (Biological)
结局指标
主要结局
Assessment of subjective and objective effects of CBD on the outcomes of healing scars
时间窗: 2 years
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).
次要结局
未报告次要终点