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Enrolling by invitation NCT06994520

Efficacy of Topical Cannabidiol for Eczema

Phase II Interventional Chronic Pruritus Eczema Nummular Eczema Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cannabidiol (CBD), Triamcinolone (TAC) 0.1% cream.
Who it may be relevant to
Registry conditions: Chronic Pruritus, Eczema, Nummular Eczema, Atopic Dermatitis. Basic parameters: from 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of Topical Cannabidiol in Patients With Eczema

Overview

Itching is a common symptom encountered in general medical practice. It can cause significant discomfort, disrupt sleep, and impair patients' quality of life. Chronic pruritic skin conditions such as atopic dermatitis, nummular eczema, lichen simplex chronicus, and prurigo nodularis are frequently observed. The pathogenesis of these conditions remains incompletely understood, and effective long-term treatment options are limited. Current therapies include topical corticosteroids, topical calcineurin inhibitors, oral corticosteroids, and systemic immunosuppressants. However, these treatments are often associated with adverse effects, and the diseases tend to follow a chronic, relapsing course. Therefore, the investigators aim to investigate the efficacy and safety of topical cannabis extract in patients with chronic pruritic skin conditions.

Interventions

  • Other Cannabidiol (CBD)
    5%CBD cream
  • Drug Triamcinolone (TAC) 0.1% cream
    comparator

Primary outcome measures

  • Disease severity [Time frame: 4 weeks]
  • Changing of erythema [Time frame: 4 weeks]
  • Changing of induration [Time frame: 4 weeks]
  • Changing of scaling [Time frame: 4 weeks]
  • Changing of scratching [Time frame: 4 weeks]
  • Itching severity [Time frame: 4 weeks]
Secondary outcome measures (1)
  • Adverse events [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

  • All participants must be aged 25 years or older.
  • Patients must be diagnosed with eczema, including atopic dermatitis, nummular eczema, lichen simplex chronicus, or prurigo nodularis, with pruritus persisting for more than 6 weeks.
  • Patients must be willing to refrain from using other topical products throughout the 4-week study period.
  • Patients must provide written informed consent to participate in the study.

Exclusion criteria

  • Patients who have taken oral steroids, immunosuppressive drugs, or received phototherapy within the past 3 months.
  • Patients with chronic kidney disease, liver cirrhosis, cancer, or thyroid disease.
  • Pregnant or breastfeeding women, or women planning to become pregnant.
  • Patients who develop erythematous itchy rash in response to an open patch test using cannabis extract products.
  • Patients with a known allergy to cannabis-derived products, which may result from other ingredients and/or solvents used in the extraction process.
  • Patients with severe or unstable cardio-pulmonary diseases (e.g., angina, peripheral vascular disease, cerebrovascular disease, or arrhythmia), or those at risk of cardiovascular disease.
  • Patients with a history of psychosis, current active mood disorder, or anxiety disorder.
  • Patients who are addicted to substances, including nicotine, or are heavy alcohol users.
  • Patients using other medications, particularly opioids or sedatives such as benzodiazepines.
  • Patients taking medications known to potentially interact with cannabis extracts, such as warfarin, fluoroquinolones, or dihydropyridine calcium channel blockers.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Khon Kaen University — Khon Kaen

Identifiers

NCT: NCT06994520 · HE671500

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗