A Double-blind, Superiority, and Randomized Controlled Trial to Evaluate the Efficacy of a Novel Cannabidiol Cream for Treatment of Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The success rate in ISGA score at day 15 with an improvement of grade 2 or greater.
研究概览
简要总结
To compare the efficacy of a JW-100 cream with active control (commercially available as EUCRISA®, Pfizer) for the treatment of atopic dermatitis (AD) in adult patients with mild to moderate AD measured with the Investigator's Static Global Assessment (ISGA) scale.
详细描述
Atopic dermatitis (AD) is one of the most common inflammatory skin diseases, affecting 13% of children and approximately 7% of adults in the United States. AD is often stimulated by a cascade of inflammatory events; thus, corticosteroids, immunosuppressive drugs, and antihistamines are often prescribed. Many industrialized countries have legalized botanical cannabis and its extracts for medical purposes. The most clinically relevant components of botanical cannabis are the cannabinoid agents delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), and the noncannabinoids compounds, terpenoids, and flavonoids. The aim of this study is to explore the efficacy of a novel cannabidiol cream in the treatment of atopic dermatitis in comparison with a commercially available product from Pfizer (EUCRISA®).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age.
- •Subject has a clinical diagnosis of stable AD characterized by at least three of the following four features:
- •Typical morphology and distribution (e.g., flexural lichenification or linearity in adults)
- •Chronic or chronically-relapsing eczematous/atopic dermatitis
- •Personal or family history of atopy (i.e., asthma, allergic rhinitis, AD)
- •Subject has an area of AD (excluding the scalp) covering ≥5% and ≤20% body surface area
- •Subject has an Investigator's Static Global Assessment score of 2 or 3
- •If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use a protocol approved method of birth control for the duration of the study
- •Subject is non-pregnant and non-lactating
- •Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of AD or which exposes the subject to an unacceptable risk by study participation
- •Subject is willing and able to follow all study instructions and to attend all study visits
- •Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)
排除标准
- •Subject has, in the investigator's opinion, spontaneously improving or rapidly deteriorating AD
- •Subject has, in the investigator's opinion, clinically infected AD
- •Subject has any signs or symptoms associated with topical AD therapy (e.g., history of anaphylaxis, hypersensitivity reactions, skin atrophy, striae, pigmentary changes) which, in the investigator's opinion, puts the subject at undue risk by study participation or interfere with the study conduct or evaluations
- •Subject has used any systemic immunosuppressive or immunomodulatory therapy (e.g., etanercept, alefacept, infliximab) with 16 weeks prior to Visit 1
- •Subject has used any phototherapy (e.g., ultraviolet A, ultraviolet B) for AD within four weeks prior to Visit 1
- •Subject has used any systemic AD therapy (e.g., systemic corticosteroids [including intranasal and inhaled corticosteroids at doses >2mg of prednisone or equivalent per day], cyclosporine, immunosuppressants/immunomodulators, Janus Kinase inhibitors, methotrexate, cytostatics) within four weeks prior to Visit 1
- •Subject has used any systemic antibiotics within two weeks prior to Visit 1
- •Subject has used any topical AD therapy (e.g., corticosteroids, calcineurin inhibitors, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) on the planned treatment area within one week prior to Visit 1
- •Subject is currently using antihistamines (e.g., diphenhydramine, terfenadine) UNLESS the subject has been on a stable dose for at four weeks and agrees to continue that dose for the duration of the study
- •Subject has a history of sensitivity to any of the ingredients in the study medications
- •Subject has any concomitant medical condition which, in the investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
- •Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.
研究组 & 干预措施
JW-100
Subjects applying JW-100 cream twice daily at home (experimental group).
干预措施: JW-100 (Other)
EUCRISA
Subjects applying EUCRISA® (Pfizer) product twice daily at home (comparator group).
干预措施: Eucrisa (Drug)
结局指标
主要结局
The success rate in ISGA score at day 15 with an improvement of grade 2 or greater.
时间窗: 15 days
The proportion of patients showing grade 2 or greater improvement using the the Investigator's Static Global Assessment (ISGA) scale.
次要结局
- The success rate of patients with an ISGA score of clear (0) or almost clear (1) at day 15.(15 days)
- Time to achieve success in ISGA scores 0 and 1.(15 days)
- Percentage mean change from baseline in the severity of AD signs (erythema, exudation, excoriation, induration/papulation, and lichenification).(15 days)
- Proportion of patients achieving improvement in the severity of the pruritus.(15 days)
- Time to improvement in pruritus (scores 0 and 1)(15 days)