A Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AOBiome LLC
- 入组人数
- 122
- 试验地点
- 33
- 主要终点
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
研究概览
简要总结
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD
详细描述
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD
At Screening and Baseline, all subjects must have atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% and a maximum of 30% body surface area, EASI score of 10 to 21 and pruritus visual analogue scale scores of ≥ 5 points on the VAS scale (at least moderate).
The total duration of the study will be approximately 9 weeks. Participants will report for a Screening visit and if all inclusion criteria are met, subjects will go through a two week washout phase before reporting for a Baseline visit.
Subjects will come in for visits at Day 14 (Week 2), Day 28 (Week 4). A final visit will be conducted at Day 42 (Week 6).
Efficacy will be assessed using Atopic Dermatitis Area and Severity Index (EASI) and Visual Analog Scale (VAS).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double blind study. Participants will be assigned to study treatment in accordance with the randomization schedule generated for the allocation of vehicle or B244 prior to the initiation of the trial. Randomization will be centrally-based and performed using an appropriate IWRS (an automated randomization system).
Each participant scheduled to receive investigational product (IP) will receive a randomization number at the time of randomization. The randomization number will be used to identify the study medication kit assigned to the participant and indicate the treatment to be administered to that participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ≥18 years of age
- •In good general health as determined by a thorough medical history and physical examination, and vital signs
- •Clinical diagnosis of mild to moderate atopic dermatitis according to the criteria of Hanifin and Rajka
- •Mild to moderate Atopic Dermatitis area and severity index [EASI] 10-21
- •A score of at least ≥ 5 points (moderate pruritus) on the VAS for pruritus
- •A minimum of 10% and not more than 30% of the subjects' BSA affected by atopic dermatitis (affected is defined by physical examination findings: erythema, edema, scaling, lichenification, excoriation, with the excoriation serving as the physical examination correlate of pruritus)
- •An IGA score of 2-3
- •Patient has a history of AD for ≥12 months
- •Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure
排除标准
- •Pregnant and lactating women by urine pregnancy testing
- •Subjects with any significant clinical abnormalities which may interfere with study participation
- •Any skin condition which may interfere with evaluation of AD
- •Atopic dermatitis only on the head or scalp
- •Subjects with Atopic dermatitis on the face
- •Unstable or actively infected atopic dermatitis
- •Patients suffering from pruritus from conditions other than AD
- •Patients with chronic pruritus due to systemic disease
- •Patients with conditions requiring inhaled steroids
- •Have concurrent skin disease of such severity in the study area that it could interfere with the study evaluation
- •Have active skin infections on the treatment area
- •Have received or planning to receive topical corticosteroids, topical coal tar, topical sulfur, topical PDE-4 inhibitors, topical antihistamines, topical antiseptics or antibiotics, topical antifungals, bleach baths, UVA or UVB phototherapy, oral/IV/inhaled steroids, antibiotics/antiviral/antifungal agents, oral probiotics, glucocorticoids treatment, calcineurin inhibitors, immunomodulating biologic agents, systemic glucocorticoids, systemic immunosuppressive or immunomodulatory agents within 2 weeks of Baseline visit.
- •Current or recent history (≤3 months of systemic use of Otrexup™, Rasuvo®, Rheumatrex® and Trexall™ or its generic versions such as Methotrexate
- •History of being seropositive for human immunodeficiency virus (HIV) at screening by laboratory testing at Screening
- •History of being positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening by laboratory testing at Screening
- •History of renal disease
- •Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than five times the drug's half-life, whichever is longer
- •Use of any biologic within a period of 5 times its half-life
- •Use of vinegar or bleach baths within 2 weeks of starting the study
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
时间窗: Baseline to Day 42
Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
次要结局
- Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups(Baseline to Day 28)