Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa
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|ClinicalTrials.gov Identifier: NCT03929835|
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Drug: Cannabis oil Drug: Placebo||Phase 2|
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.
The duration of study participation for each subject is expected to be 12 weeks (84 days), about 4 weeks from visit 0 until receiving the license and 8 weeks trial,of which, six weeks of dose titration. Over the course of twelve weeks, four visits will be conducted and there will be 3 telephone evaluations. During first visit screening and enrolment will be conducted. The second visit will take place four weeks later where patients will receive the oils and start the trial, followed by a phone call evaluation at day 5-7 after starting the treatment and at week 2±2 days. Than a visit approximately four weeks later, following another phone call evaluation at week 5±2 days from treatment beginning, F Last visit will be conducted at week 8±3 days. In each visit, the relevant variables will be collected (Please refer to Table 3. Schedule of events). At the end of the eight-week experiment, patients from the treatment and control groups will be given the option to use the Avidekel oil for a period of one year. First, all the patients will use the drug in the open label phase for 8 weeks, during this period 3 phone calls and 2 visits in the hospital will be conducted, using PI-NRS and HS-PGA score to evaluate treatment success. Patients who will have at least 1 point reduction on the HS-PGA score will be permitted to continue to the 1 year follow-up. During that period 2 visits, six months and one year, will be conducted and the relevant variables will be collected (see Table 3). All visits will take place at the hospital.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Experimental: 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.
Drug: Cannabis oil
Placebo Comparator: Placebo
Patients in the control group will receive placebo oil containing olive oil and Chlorophyll.
Olive oil with chlorophyl
- Clinical response [ Time Frame: From Week 0 to Week 8 ]1 point reduction in HS-PGA score in treatment vs. control at week 8
- Safety: Participants experiencing Adverse Events (AE's) or Serious Adverse Events (SAE's) [ Time Frame: Week 3, Week 6, six months and 12 months ]Participants experiencing Adverse Events (AE's) or Serious Adverse Events (SAE's)
- Efficacy: Hidradenitis suppurativa Severity Index (HSSI) [ Time Frame: 6 weeks, six months and 12 months ]Hidradenitis suppurativa Severity Index (HSSI)
- Clinical response [ Time Frame: 6 weeks of treatment ]Hidradenitis Suppurativa Clinical Response (HiSCR)
- Changes from baseline [ Time Frame: From Week 0 to Week 6, six months and 12 months ]Dermatology Quality of Life Index (DLQI)
- Efficacy on pain levels: VAS pain scale [ Time Frame: From Week 0 to Week 8, 16 weeks, six months and 12 months ]VAS pain scale 11-point numerical pain rating scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929835
|Contact: Michael Ziv, Dr. +972.8. 6494122 firstname.lastname@example.org|