Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa

NCT03929835 | Withdrawn Phase 2

• 1 other identifier: TO_HS01_2017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hidradenitis Suppurativa

Keywords

Cannabis

Outcome Measures

Primary Outcomes (1)

• Clinical response

  1 point reduction in HS-PGA score in treatment vs. control at week 8

  From Week 0 to Week 8

Secondary Outcomes (5)

• Safety: Participants experiencing Adverse Events (AE's) or Serious Adverse Events (SAE's)

  Week 3, Week 6, six months and 12 months

• Efficacy: Hidradenitis suppurativa Severity Index (HSSI)

  6 weeks, six months and 12 months

• Clinical response

  6 weeks of treatment

• Changes from baseline

  From Week 0 to Week 6, six months and 12 months

• Efficacy on pain levels: VAS pain scale

  From Week 0 to Week 8, 16 weeks, six months and 12 months

Study Arms (2)

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.

Drug: Cannabis oil

Placebo

PLACEBO COMPARATOR

Patients in the control group will receive placebo oil containing olive oil and Chlorophyll.

Drug: Placebo

Interventions

Cannabis oil DRUG

T1/C20 CBD

Also known as: Avidekel Oil

Avidekel Oil

Placebo DRUG

Olive oil with chlorophyl

Also known as: Olive oil with chlorophyl

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• TO Pharmaceuticals: lead

Study Sites (1)

Haemek Hospital

Afula, Israel

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa; Marijuana Abuse

Interventions

nabiximols; Olive Oil

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

IL (1)