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

• Status: Withdrawn
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TO Pharmaceuticals
• Treatments: Chlorophyllin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• Patients with medical cannabis license

• Patients suffering from kidney disease