Atopic Dermatitis, Chronic Pruritus, Eczema, Nummular Eczema, Prurigo Nodularis
Conditions
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.
Interventions
OTHERCannabidiol (CBD)
5%CBD cream
comparator
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Topical cannabidiol versus 0.1% TA cream
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease severity | 4 weeks | Disease severity was evaluated using a composite scoring system that assessed four clinical signs-erythema, induration, scaling, and scratching-along with the extent of area involvement. Each sign was graded on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The extent of area involvement was classified into six categories based on the percentage of body surface area affected: 1 = less than 10%; 2 = 10-\<30%; 3 = 30-\<50%; 4 = 50-\<70%; 5 = 70-\<90%; 6 = 90-100%. The overall severity score was obtained by summing the individual scores for erythema, induration, scaling, and dryness for each affected area and then multiplying this sum by the corresponding area involvement score. Higher total scores indicated greater disease severity. |
| Changing of erythema | 4 weeks | Erythema was graded on a scale from 0 to 3, with 0 indicating no redness, 1 mild, 2 moderate, and 3 severe redness. |
| Changing of induration | 4 weeks | Induration was graded on a scale from 0 to 3, with 0 indicating no induration, 1 mild, 2 moderate, and 3 severe skin thickening. |
| Changing of scaling | 4 weeks | Scaling (flaking of the skin) was graded on a scale from 0 to 3, with 0 indicating none, 1 mild, 2 moderate, and 3 severe. |
| Changing of scratching | 4 weeks | Excoriation (scratching marks) was graded on a scale from 0 to 3, with 0 indicating no excoriation, 1 mild, 2 moderate, and 3 severe excoriation. |
| Itching severity | 4 weeks | Itching severity was assessed using an 11-point numeric rating scale (NRS). The NRS-11 evaluates average intensity of pruritus ranging from 0 (no itch) to 10 (worst imaginable itch). Scores were classified into three groups as follows: 0-3 = mild, 4-7 = moderate, and 8-10 = severe. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | 4 weeks |
Countries
Thailand
Outcome results
None listed