A Phase Ⅱ, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Clinical response
研究概览
简要总结
Hidradenitis Suppurativa (HS), is a chronic skin disease, manifested as inflamed areas of hair follicles around apocrine sweat glands found in areas most commonly the axillae, inguinal and anogenital regions. Patients experience great deal of physical pain as well as profound psychological problems. HS patients may also be prone to health complications and diseases. Treatment to date is limited and consist mainly of antibiotic administration and novel biological drug with up to 40% efficiency. Recently it was shown that cannabinoids reduces the folliculo pilosebaceous activity, most likely due to activating arachnoiditis, lipostat , anti-proliferative and anti-inflammatory agents and reduce inflammation inducing cytokines.
详细描述
Forty participants will be recruited over two years. After determine eligibility by examining the study criteria for inclusion and exclusion, the patient will be asked to sign the informed consent form.
The YAKAR form of medical cannabis license application and a confidentiality waiver form will be sent to the YAKAR. The physician will explain to the patients that his/her participation in the trial can be terminated at any time and will explain the medical license conditions: It is absolutely forbidden to:
- Use cannabis in the presence of minors or in public
- Drive under the influence of cannabis
- The participant shall take measures to prevent the theft of cannabis and inform the Investigator and the YAKAR of an attempt to steal or lose of cannabis.
When the patient license arrives, the patient will be scheduled an appointment for the first visit of the trial at the hospital. Tikun-Olam will be informed and asked to supply the patient product on the visit day. The copy of the patient's license will be included into the trial source documents.
The participants will be randomly assigned in a 1:1 ratio to receive Avidekel oil or placebo oil. Patients will receive the oils as drops applied under the tongue 3 times a day.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects >
- •Subjects who are diagnosed with moderate to severe Hidradenitis Suppurativa for at least 12 months prior to screening.
- •Written informed consent from participant.
- •For women, consent to avoid pregnancy during the trial.
- •Consent to avoid driving during the influence of cannabis
排除标准
- •Patients receiving any of the following medications: Astemizole, Cisapride, Pimozide or Terfenadine.
- •Patients with severe heart disease.
- •Subjects suffering from Epilepsy.
- •Subjects suffering from anxiety disorder.
- •Subjects who had psychotic condition in the past OR suffering from psychosis.
- •Schizophrenia OR family history of Schizophrenia OR any other mental disorder.
- •Significant psychiatric inheritance in a first-degree family member, especially in patients under
- •Pregnancy or intention to become pregnant during the study period
- •Subjects with any other condition, which in the judgment of the investigator would prevent the subject from completing the study.
- •Subjects suffering from chronic pain that does not necessarily is an outcome of the HS (Fibromyalgia, slipped disc).
- •Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient.
- •Patients suffering from alcohol and/or substance abuse
- •Surgery within 30 days prior to screening or scheduled surgery during the study period.
- •Current participation in another drug or device clinical trial, or participation in such a clinical trial
- •Lack of cooperation until the end of the study period.
- •Patients with medical cannabis license
- •Patients suffering from kidney disease
研究组 & 干预措施
Avidekel Oil
The cannabis oil, sort T1/C20 CBD as categorized by the MOH guidelines will be made from Avidekel strain and olive oil extract. Avidekel oil contains Δ9-Tetra-Hydrocannabinol (Δ9-THC) and Cannabidiol (CBD) in a 1:20 ratio and at a concentration of 30% CBD and 1.5% Δ9-THC. Each Avidekel oil drop is approximately 0.04 ml in volume containing about 12 mg CBD and 0.6 mg Δ9-THC.
干预措施: Cannabis oil (Drug)
Placebo
Patients in the control group will receive placebo oil containing olive oil and Chlorophyll.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical response
时间窗: From Week 0 to Week 8
1 point reduction in HS-PGA score in treatment vs. control at week 8
次要结局
- Efficacy on pain levels: VAS pain scale(From Week 0 to Week 8, 16 weeks, six months and 12 months)
- Clinical response(6 weeks of treatment)
- Efficacy: Hidradenitis suppurativa Severity Index (HSSI)(6 weeks, six months and 12 months)
- Safety: Participants experiencing Adverse Events (AE's) or Serious Adverse Events (SAE's)(Week 3, Week 6, six months and 12 months)
- Changes from baseline(From Week 0 to Week 6, six months and 12 months)