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NCT Number: NCT06435299

Efficacy and Tolerance of THC 25: CBD 25 in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study

Chronic pruritus affects 10-20% of the population and causes a major reduction in quality of life, comparable to pain, with significant psychological, social, and functional consequences. Current treatments are often insufficient, highlighting the urgent need for new therapeutic options.

Recent advances in the pathophysiology of itch have shown the involvement of the endocannabinoid system (CB1, CB2, and TRPV1 receptors) in modulating itch signal transmission and cutaneous inflammation. Cannabinoids, particularly the balanced CBD:THC combination, appear promising as they provide both central and peripheral antipruritic effects, while CBD helps mitigate the psychotropic side effects of THC.

Preclinical studies and limited clinical data suggest efficacy across various forms of pruritus (dermatological, uremic, cholestatic), though robust controlled trials are still lacking. Evidence from nabiximols (1:1 CBD:THC spray) in other conditions such as neuropathic pain and spasticity further supports the rationale for this approach.

Therefore, sublingual LGP THC25:CBD25 oil has been selected for its balanced ratio, simple administration route, and expected tolerability, to evaluate its efficacy and safety in the treatment of chronic pruritus.

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Key information

Conditions

Pruritus Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Severe pruritus, defined by a mean WI-NRS score ≥7/10 (evaluated on one week before inclusion, regardless of the cause of the pruritus
  • Insufficient relief (WI-NRS ≥7/10 ) or poor tolerance (adverse effects) of accessible drug and non-drug therapies
  • Stable treatment (for treatment of the prurit) for at least 6 weeks
  • Affiliated or benefiting of a social security
  • Informed consent (personally dated and) signed by the participant or any representatives (impartial witness/trusted person)

Exclusion criteria

  • Patients unable to consent.
  • Patients refusing to participate in research.
  • Patients under guardianship or conservatorship.
  • Personal history of psychotic disorders.
  • Severe hepatic impairment, defined as prothrombin level <50% or with predictive biological impairment.
  • Moderate to severe renal impairment, with an estimated glomerular filtration rate ≤ 44 mL/min/1.73 m².
  • Severe cardiovascular or cerebrovascular disease, including history of myocardial infarction or stroke.
  • Pregnant or breastfeeding women.
  • Lack of understanding of questionnaires or inability to follow up.
  • Women of childbearing potential unwilling to use appropriate contraception.
  • Cannabinoid use outside the clinical trial
  • Use of cannabis or its derivatives less than one week before inclusion
  • History of hypersensitivity or allergy to any cannabinoid product.
  • Allergy to nuts.

Treatment and study plan

Cannabis oil

Drug

Patients in this arm will have to take Cannabis oil (50mg/mL) twice a day with the daily dose estimated during auto titration phase (from W0 to W2)

Placebo

Drug

Patients in this arm will have to take Placebo oil twice a day with the daily dose estimated during auto titration phase (from W0 to W2)

Primary outcomes

  1. WI-NRS change

    Time frame: Week 0

    Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.

  2. WI-NRS change

    Time frame: Week 6

    Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.

Secondary outcomes

  1. WI-NRS change from W0 to W2

    Time frame: Week 0

    • Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2

  2. WI-NRS change from W0 to W2

    Time frame: Week 2

    • Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2

  3. WI-NRS change from W2 to W6

    Time frame: Week 2

    Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from week 2 to week 6.

  4. WI-NRS change from W2 to W6

    Time frame: Week 6

    Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from week 2 to week 6.

  5. ItchyQoL change from W0 to W2

    Time frame: Week 0

    • Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)

  6. ItchyQoL change from W0 to W2

    Time frame: Week 2

    • Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)

  7. ItchyQoL change from W2 to W6

    Time frame: Week 2

    • Percent change in ItchyQoL score from Week 2 visit to week 6 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)

  8. ItchyQoL change from W2 to W6

    Time frame: Week 6

    • Change in ItchyQoL score from Week 2 visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)

  9. Chronic Itch Burden Scale change from W0 to W2

    Time frame: Week 0

    • Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)

  10. Chronic Itch Burden Scale change from W0 to W2

    Time frame: Week 2

    • Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)

  11. Chronic Itch Burden Scale change from W2 to W6

    Time frame: Week 2

    • Percent change in Chronic Itch Burden Scale - 10 from Week 2 visit to week 6 (10 questions rated from "Not at all" to "Very much" on patient itching)

  12. Chronic Itch Burden Scale change from W2 to W6

    Time frame: Week 6

    • Percent change in Chronic Itch Burden Scale - 10 from Week 2 visit to week 6 (10 questions rated from "Not at all" to "Very much" on patient itching)

  13. Treatment adverse events

    Time frame: Week 0

    • Incidence and severity of treatment-emergent adverse events.

  14. Treatment adverse events

    Time frame: Week 2

    • Incidence and severity of treatment-emergent adverse events.

  15. Treatment adverse events

    Time frame: Week 4

    • Incidence and severity of treatment-emergent adverse events.

  16. Treatment adverse events

    Time frame: Week 6

    • Incidence and severity of treatment-emergent adverse events.

  17. Treatment adverse events

    Time frame: Week 8

    • Incidence and severity of treatment-emergent adverse events.

  18. Treatment Observance Rate

    Time frame: Week 6

    • Number of observant patients (YES/NO) in both arms: Observance (defined as YES) is considered as taking at least one dose of treatment per day over the W0 - W6 period.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent MISERY, PU-PH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: CANNA-ITCH

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
May 30, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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