Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03929835 |
| Other study ID # |
TO_HS01_2017 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
September 1, 2022 |
Study information
| Verified date |
July 2021 |
| Source |
TO Pharmaceuticals |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
