Efficacy of Topical Cannabidiol in Patients With Eczema
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Disease severity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Triamcinolone cream
干预措施: Triamcinolone (TAC) 0.1% cream (Drug)
Cannabinoid
干预措施: Cannabidiol (CBD) (Other)
结局指标
主要结局
Disease severity
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Adverse events(4 weeks)
研究者
Suteeraporn Chaowattanapanit
Associate Professor
Khon Kaen University