A Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 10
- 主要终点
- Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions
研究概览
简要总结
This is a randomized, placebo-controlled Phase 2 trial consisting of up to 300 subjects with either psoriasis or atopic dermatitis. In this trial BMX-010 will be topically applied twice daily for up to 28 days.
详细描述
This is a Phase 2, randomized, multicenter, placebo-controlled study sponsored by BioMimetix JV, LLC (BMX). It is a double-blind parallel cohort study designed to determine the safety and efficacy of BMX-010 (0.03%) relative to Placebo in subjects with atopic dermatitis and psoriasis.
Subjects will be queried regarding adverse events (AEs) and concomitant medication usage.
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
Double-blind
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
- •Diagnosis of either atopic dermatitis or psoriasis with mild to moderate lesions involving 1% - 25% of total body surface area
- •Candidate for topical treatment of atopic dermatitis or psoriasis
- •Negative pregnancy test for females of childbearing potential
排除标准
- •Systemic pharmacotherapy or phototherapy for treatment of atopic dermatitis or psoriasis
- •Erythrodermic, guttate or generalized pustular psoriasis
- •Treatment of systemic retinoids, corticosteroids or immunosuppressive agents within 4 weeks of baseline visit
- •Treatment with high potency topical steroids, vitamin D analogs, keratolytics, coal tar, phototherapy, calcineurin inhibitors, or antihistamines within 2 weeks of baseline visit
- •UV or Dead Sea therapy within 4 weeks of baseline visit
- •Treatment with a biologic agent (monoclonal antibody) within 30 days or 5 times its circulating half-life (whichever is longer) prior to baseline visit
- •Atopic dermatitis triggered by environmental allergen or irritant
- •Contact dermatitis or drug-induced skin reactions
- •Systemic or skin infection requiring antimicrobial therapy
- •Systemic chemotherapy or radiotherapy within 4 weeks of baseline visit
- •Immunocompromise of any cause
- •Pregnancy, lactation or inadequate contraception
- •Active drug or alcohol dependence
- •Significant acute or chronic medical, neurological or psychiatric illness that would compromise subject's safety
研究组 & 干预措施
Placebo
100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
干预措施: Placebo (Drug)
BMX-010 0.03%
200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
干预措施: BMX-010 (Drug)
结局指标
主要结局
Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions
时间窗: 7-28 days
Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions
Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions
时间窗: 7-28 days
Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions
Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions
时间窗: 7-28 days
Assessment of efficacy
次要结局
- Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010(8 days)
- Peak Plasma Concentrations (Cmax) for BMX-010(8 days)