An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Determine whether the optimum frequency of topical application of BMX-010 0.03% is once per day or twice per day for a treatment interval of up to 28 days.
研究概览
简要总结
This is an exploratory Phase 2 trial of BMX-010 in patients with Rosacea which will be conducted in two parts. Up to 210 subjects with Rosacea will be enrolled.
详细描述
Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the study drug. Up to 60 subjects will be enrolled in this part.
Part B is designed to be a randomized, double-blind trial studying the optimal formulation, strength, and dosing frequency of BMX-010 as determined in Part A, compared to Placebo. Up to 150 subjects will be enrolled in this part.
In both parts, adult subjects with Rosacea will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
In Part A, all subjects will receive study drug and this is Open Label. When Part A is complete, Part B will start and this will be double blind to participant and investigators.
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 or female, at least 18 years of age;
- •A clinical diagnosis of mild to severe facial rosacea;
- •Screening and Baseline IGA score > 2 (greater than or equal to 2);
- •A minimum Clinician Erythema Assessment (CEA) score of 2 at Screening and at Baseline Visits (prior to the investigational product application);
- •Willing to refrain from using any topical or systemic treatments for inflammatory skin disease, other than the investigational product;
- •Candidate for topical treatment of Rosacea;
- •If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup;
- •Females of child-bearing potential must have a negative urine pregnancy test within 48 hours prior to the first drug administration;
- •Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the investigator (for example, oral contraceptive pills plus a barrier method) through the trial and for 1 month thereafter to be eligible for, and continue participation in, the study;
- •Ability to complete the study in compliance with the protocol, including agreement in writing to apply study product only to the assigned areas; and
- •Ability to understand and provide written informed consent.
排除标准
- •Any dermatological conditions on the face that could interfere with clinical evaluations;
- •Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
- •Presence of beard or excessive facial hair at Screening which would interfere with the study treatments or study assessments and refusal to remove for duration of study;
- •Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study;
- •Concomitant skin disease that could confound clinical evaluations or increase risk to the subject;
- •Use of medicated make-up (including anti-aging make-up) throughout the study;
- •Use during the study of 1) systemic steroids, 2) topical retinoids to the face, 3) antibiotics known to impact rosacea, 4) immunosuppressive agents, or immunomodulators;
- •Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics;
- •Use of medicated cleansers on the face (throughout the study);
- •Use of topical astringents or abrasives, medical topical preparations (prescription and OTC products) within 2 days prior to Baseline and throughout the study;
- •Systemic or skin infection requiring antimicrobial therapy;
- •Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit;
- •Immunocompromise of any cause, known human immunodeficiency virus infection, or acquired immunodeficiency syndrome;
- •Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the investigator;
- •Active drug or alcohol dependence;
- •Significant acute or chronic medical, neurological, or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study;
- •Previous clinical trial participation for the indication being treated in this protocol.
研究组 & 干预措施
BMX-010 0.03%
Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Rosacea of the face.
干预措施: BMX-010 (Drug)
BMX-010 0.1%
Approximately 30 subjects will receive BMX-010 0.1% for 7-28 days to be applied topically to Rosacea of the face.
干预措施: BMX-010 (Drug)
结局指标
主要结局
Determine whether the optimum frequency of topical application of BMX-010 0.03% is once per day or twice per day for a treatment interval of up to 28 days.
时间窗: 28 days
Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade which will be assessed weekly.
Determine whether the optimum frequency of topical application of BMX-010 0.1% is once per day or twice per day for a treatment interval of up to 28 days.
时间窗: 28 days
Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade which will be assessed weekly.
Determine if BMX-010 cream or gel provides better efficacy in the treatment of the redness of rosacea.
时间窗: 43 days
Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).
Evaluate the efficacy of BMX-010 in treatment of rosacea.
时间窗: 43 days
Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).
Determine if BMX-010 cream or gel provides better efficacy in the treatment of rosacea.
时间窗: 43 days
Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).
Evaluate the effect of BMX-010 on redness in patients with rosacea.
时间窗: 43 days
Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).
次要结局
- Assess the mean percent reduction change in inflammatory papules/pustules counts from baseline to end of study.(43 days)
- Document, as possible, the clinical effects of BMX-010 in subjects with Rosacea through clinical photography.(43 days)