Hidradenitis SuppurativaPhase 2NCT03929835
Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa
A Phase 2 study testing Cannabis oil in people with Hidradenitis Suppurativa, run by TO Pharmaceuticals at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Cannabis oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects >20.
- 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
Who cannot join
- 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.
Show all 17Show fewer
- Significant psychiatric inheritance in a first-degree family member, especially in patients under 30.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Cannabis oil, Placebo
- Keywords
- Cannabis
- Medical subject headings
- Hidradenitis Suppurativa, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis oilDrug
Also called Avidekel Oil
T1/C20 CBD
PlaceboDrug
Also called Olive oil with chlorophyl
Olive oil with chlorophyl
| Study group | Role | What they receive |
|---|---|---|
| Avidekel Oil | Experimental | 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. Receives: Drug: Cannabis oil |
| Placebo | Placebo comparator | Patients in the control group will receive placebo oil containing olive oil and Chlorophyll. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
1 point reduction in HS-PGA score in treatment vs. control at week 8
Measured: From Week 0 to Week 8
Secondary outcomes (5)
Safety: Participants experiencing Adverse Events (AE's) or Serious Adverse Events (SAE's)
Participants experiencing Adverse Events (AE's) or Serious Adverse Events (SAE's)
Measured: Week 3, Week 6, six months and 12 months
Efficacy: Hidradenitis suppurativa Severity Index (HSSI)
Hidradenitis suppurativa Severity Index (HSSI)
Measured: 6 weeks, six months and 12 months
Clinical response
Hidradenitis Suppurativa Clinical Response (HiSCR)
Measured: 6 weeks of treatment
Changes from baseline
Dermatology Quality of Life Index (DLQI)
Measured: From Week 0 to Week 6, six months and 12 months
Efficacy on pain levels: VAS pain scale
VAS pain scale 11-point numerical pain rating scale
Measured: From Week 0 to Week 8, 16 weeks, six months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: withdrawn due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TO Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929835
- Sponsor's protocol ID
- TO_HS01_2017
- Status last verified
- Jul 2021
- First submitted
- 24 Apr 2019
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03929835
- Acronym / sponsor ID
- TO_HS01_2017
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Cannabis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn due to COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TO PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avidekel Oil | Experimental | Drug: Cannabis oilThe 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. |
| Placebo | Placebo comparator | Drug: PlaceboPatients in the control group will receive placebo oil containing olive oil and Chlorophyll. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects >20.
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis oilAlso: Avidekel OilT1/C20 CBD | Drug | Avidekel Oil |
| PlaceboAlso: Olive oil with chlorophylOlive oil with chlorophyl | Drug | Placebo |
Primary outcome
Clinical response
Time frame: From Week 0 to Week 8
1 point reduction in HS-PGA score in treatment vs. control at week 8
5 secondary outcomes
Safety: Participants experiencing Adverse Events (AE's) or Serious Adverse Events (SAE's)
Time frame: Week 3, Week 6, six months and 12 months
Efficacy: Hidradenitis suppurativa Severity Index (HSSI)
Time frame: 6 weeks, six months and 12 months
Clinical response
Time frame: 6 weeks of treatment
Changes from baseline
Time frame: From Week 0 to Week 6, six months and 12 months
Efficacy on pain levels: VAS pain scale
Time frame: From Week 0 to Week 8, 16 weeks, six months and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabis oil in people with Hidradenitis Suppurativa, run by TO Pharmaceuticals at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: From Week 0 to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.