Oral and Topical Use of Phytocannabinoids for Patients With Psoriasis Vulgaris: An Open-Label Prospective Study - CBDermis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index (PASI) total score
研究概览
简要总结
Psoriasis is a chronic inflammatory skin disease that affects approximately 2% of the global population and is frequently associated with psychiatric comorbidities such as anxiety and depression. Although conventional treatments, including topical corticosteroids and biologic agents, may be effective, many patients face challenges related to treatment adherence, adverse effects, and the psychosocial impact of the disease. This open label study aims to investigate the efficacy and acceptability of medicinal cannabis formulations administered orally and topically in the management of mild to moderate psoriasis. 37 participants will be included and will use full spectrum cannabis formulations in the (1:1:1) CBD:CBG:THC ratio at a concentration of 20 mg/ml. The protocol will have a total duration of 180 days, consisting of 60 days of isolated treatment followed by 120 days of combined treatment. Efficacy will be assessed using validated instruments, including PASI, DLQI, BDI II and BAI, the Visual Analog Scale for pruritus intensity, the Cosmetic Acceptability Scale, and the Treatment Satisfaction Scale. The use of cannabis formulations is expected to promote clinical improvement of skin lesions, reduction of subjective symptoms such as pruritus and discomfort, and a positive impact on patients quality of life. This study seeks to contribute to the generation of evidence, regarding the efficacy, safety, and acceptability of therapeutic cannabis use in the dermatological context.
详细描述
This study aims to evaluate the effects of oral and topical cannabinoid administration in patients with psoriasis over a 180-day period.
Oral administration will be performed using a full-spectrum extract containing CBD:CBG:THC in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid. Dose titration will be conducted progressively according to individual tolerability. The dosing schedule will follow a stepwise escalation: 0.08 mL/day in the first week (approximately 1.6 mg/day of each cannabinoid), 0.17 mL/day in the second week (approximately 3.3 mg/day of each cannabinoid), and 0.25 mL/day in the third week (5 mg/day of each cannabinoid). From the second month onward, the dose will be increased to 0.5 mL/day (10 mg/day of each cannabinoid), defined as the maximum study dose, and maintained until the end of the intervention period.
Topical administration will be performed using a cream containing CBD:CBG:THC, in the same proportion as the oral extract, with a concentration of 20 mg/mL of each cannabinoid. The product will be applied directly to psoriasis lesions twice daily throughout the study period. No titration will be performed for the topical formulation, and a fixed-dose regimen will be maintained.
The study will follow a two-phase design. Participants will be initially allocated into two groups: Group 1 (oral) will receive the oral extract for the first 60 days, while Group 2 (topical) will use the topical formulation during the same period. In the second phase (days 60-180), all participants will receive combined treatment (oral extract plus topical formulation). This design allows evaluation of both isolated and combined therapeutic effects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of psoriasis vulgaris confirmed by a dermatologist
- •Age between 18 and 65 years
- •Psoriasis Area and Severity Index (PASI) ≤ 10 at screening
- •Patients with clinical stability over the past 3 months, without significant changes in psoriasis condition
- •Availability to attend consultations and periodic assessments during the study
- •Agreement to participate and signing of the Informed Consent Form (ICF)
排除标准
- •Patients who do not meet the inclusion criteria
- •Presence of other active inflammatory dermatological diseases that may interfere with psoriasis assessment
- •History of severe recurrent skin infections or active infection at screening
- •History of psychosis or first-degree family history of schizophrenia or epilepsy
- •Severe cardiovascular diseases
- •Severe hepatic or renal diseases
- •Use of phototherapy within the last 2 months
- •Pregnant or breastfeeding women
- •Diagnosis of psoriatic arthritis
- •Lack of availability to attend study assessments
- •Ongoing pharmacological treatment with unstable therapy or changes in lesion severity within the last 30 days
- •Refusal to sign the Informed Consent Form (ICF)
研究组 & 干预措施
Oral Cannabis Extract
Participants assigned to this arm will receive an oral full-spectrum cannabis extract containing cannabidiol (CBD), cannabigerol (CBG), and delta-9-tetrahydrocannabinol (THC) in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid.
During the first 60 days, oral administration will follow a progressive dose titration based on individual tolerability:
Week 1: 0.08 mL/day (≈1.6 mg/day of each cannabinoid) Week 2: 0.17 mL/day (≈3.3 mg/day of each cannabinoid) Week 3: 0.25 mL/day (5 mg/day of each cannabinoid) From Day 30 onward: 0.5 mL/day (10 mg/day of each cannabinoid), maintained as the maximum study dose
From Day 61 to Day 180, participants will receive combined therapy consisting of oral cannabis extract plus topical cannabis cream applied to psoriatic lesions.
干预措施: Oral Cannabis Extract (Drug)
Oral Cannabis Extract
Participants assigned to this arm will receive an oral full-spectrum cannabis extract containing cannabidiol (CBD), cannabigerol (CBG), and delta-9-tetrahydrocannabinol (THC) in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid.
During the first 60 days, oral administration will follow a progressive dose titration based on individual tolerability:
Week 1: 0.08 mL/day (≈1.6 mg/day of each cannabinoid) Week 2: 0.17 mL/day (≈3.3 mg/day of each cannabinoid) Week 3: 0.25 mL/day (5 mg/day of each cannabinoid) From Day 30 onward: 0.5 mL/day (10 mg/day of each cannabinoid), maintained as the maximum study dose
From Day 61 to Day 180, participants will receive combined therapy consisting of oral cannabis extract plus topical cannabis cream applied to psoriatic lesions.
干预措施: Topical cannabis cream (Drug)
Topical Cannabis Cream
Participants assigned to this arm will apply a topical full-spectrum cannabis cream containing cannabidiol (CBD), cannabigerol (CBG), and delta-9-tetrahydrocannabinol (THC) in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid.
During the first 60 days, the cream will be applied directly to psoriatic lesions twice daily, with a fixed-dose regimen and no titration.
From Day 61 to Day 180, participants will receive combined therapy consisting of topical cannabis cream plus oral cannabis extract administered with progressive dose titration as described
干预措施: Oral Cannabis Extract (Drug)
Topical Cannabis Cream
Participants assigned to this arm will apply a topical full-spectrum cannabis cream containing cannabidiol (CBD), cannabigerol (CBG), and delta-9-tetrahydrocannabinol (THC) in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid.
During the first 60 days, the cream will be applied directly to psoriatic lesions twice daily, with a fixed-dose regimen and no titration.
From Day 61 to Day 180, participants will receive combined therapy consisting of topical cannabis cream plus oral cannabis extract administered with progressive dose titration as described
干预措施: Topical cannabis cream (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index (PASI) total score
时间窗: Baseline and 6 months
Single aggregated composite score evaluating overall psoriasis severity across four body regions (head, trunk, upper limbs, and lower limbs) and three lesion characteristics (erythema, induration, and desquamation). Individual parameters and sub-scores are combined via the standard PASI mathematical formula to yield a single reported outcome value ranging from 0 to 72, where higher scores represent greater overall disease severity.
次要结局
- Dermatology Life Quality Index (DLQI) total score(Baseline and 6 months)
- Beck Anxiety Inventory (BAI) total score(Baseline and 6 months)
- Beck Depression Inventory (BDI-II) total score(Baseline and 6 months)
- UKU Side Effect Rating Scale total score(Baseline and 6 months)
- Psoriasis Disability Index (PDI) total score(Baseline and 6 months)
- Visual Analog Scale (VAS) score(Baseline and 6 months)
- Perceived Stress Scale (PSS) total score(Baseline and 6 months)
- Topical Cream Overall Acceptability Score(Baseline and 6 months)