Clinical trial NCT06994520: Efficacy of Topical Cannabidiol for Eczema
Official title: Efficacy of Topical Cannabidiol in Patients With Eczema
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Pruritus
Eczema
Nummular Eczema
Atopic Dermatitis
Prurigo Nodularis
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Topical cannabidiol versus 0.1% TA cream
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. All participants must be aged 25 years or older.
2. 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.
3. Patients must be willing to refrain from using other topical products throughout the 4-week study period.
4. Patients must provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patients who have taken oral steroids, immunosuppressive drugs, or received phototherapy within the past 3 months.
2. Patients with chronic kidney disease, liver cirrhosis, cancer, or thyroid disease.
3. Pregnant or breastfeeding women, or women planning to become pregnant.
4. Patients who develop erythematous itchy rash in response to an open patch test using cannabis extract products.
5. Patients with a known allergy to cannabis-derived products, which may result from other ingredients and/or solvents used in the extraction process.
6. 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.
7. Patients with a history of psychosis, current active mood disorder, or anxiety disorder.
8. Patients who are addicted to substances, including nicotine, or are heavy alcohol users.
9. Patients using other medications, particularly opioids or sedatives such as benzodiazepines.
10. Patients taking medications known to potentially interact with cannabis extracts, such as warfarin, fluoroquinolones, or dihydropyridine calcium channel blockers.

Primary outcomes:
measure: Disease severity
timeFrame: 4 weeks
measure: Changing of erythema
timeFrame: 4 weeks
measure: Changing of induration
timeFrame: 4 weeks
measure: Changing of scaling
timeFrame: 4 weeks
measure: Changing of scratching
timeFrame: 4 weeks
measure: Itching severity
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
References: