A Study of A-101 Topical Solution for the Treatment of Common Warts

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追踪信息

首次提交日期 ^ICMJE

September 20, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

September 17, 2018

预计主要完成日期

February 28, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

The primary efficacy endpoint is the proportion of subjects whose identified common warts are determined to be clear on the PWA scale (PWA=0)[ Time Frame: Day 60 ]

The primary efficacy endpoint is the proportion of subjects whose identified common warts are determined to be clear on the PWA scale (PWA=0) at Visit 10 (Day 60). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Proportion of subjects who achieve complete clearance of all identified common warts (PWA =0).[ Time Frame: Day 137 ]
Complete clearance of all identified common warts will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale.
Comparison between A-101 45% and Vehicle of the mean per subject percent of treated warts that are clear (PWA=0)[ Time Frame: Day 137 ]
Clearance of all treated warts will be assessed using the PWA scale which is a four point scale.
Comparison between A-101 45% and Vehicle of the proportion of subjects with a single wart at baseline, whose wart is clear (PWA=0).[ Time Frame: Day 60 ]
Clearance of the single wart at baseline will be assessed using the PWA scale which is a four point scale.
Comparison between A-101 45% and vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts.[ Time Frame: Day 137 ]
Clearance of all treated warts will be assessed using the PWA scale which is a four point scale.

描述性信息

简略标题 ^ICMJE

A Study of A-101 Topical Solution for the Treatment of Common Warts

正式标题 ^ICMJE

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts

简要概况

Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts

详细说明

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

研究类型 ^ICMJE

Interventional

研究阶段

Phase 3

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study
盲法: Interventional
盲法描述:The blinded vehicle solution is packaged to match the active study drug and will be stored under the same conditions.
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: A-101
hydrogen peroxide 45% topical solution
Other: Vehicle
Vehicle solution containing isopropyl alcohol and water

研究工具

Active Comparator: A-101
Topical solution, hydrogen peroxide 45%
Placebo Comparator: Vehicle
Topical solution, isopropyl alcohol and water

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

500

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

May 30, 2019

预计主要完成日期

February 28, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Subject or legal guardian is able to comprehend and is willing to sign an informed consent/assent for participation in this study. 2. Male or female ≥ 2 years old. 3. Subject has a clinical diagnosis of common warts (verruca vulgaris). 4. Subject has at least 1 and up to 6 clearly identifiable common warts located on the trunk or extremities that meet the requirements as defined below: 1. Have a longest axis that is ≥3 and ≤8 mm and have a thickness of ≤3mm 2. Be a discrete lesion, i.e. each wart meeting the entry criteria is clearly separated from other warts. 3. Be present for at least 4 weeks 4. Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations 5. Not be in an intertriginous fold 6. Periungual, subungual, genital, anal, mosaic, plantar, flat and filiform warts are excluded from treatment and evaluation. If a subject has these types of warts, but also has warts that meet the inclusion criteria, the subject will NOT be excluded from the study. 5. Each common wart identified for treatment must have a PWA ≥ 2. 6. Subject's chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value(s) as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization. 7. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of the identified common warts or which exposes the subject to an unacceptable risk by study participation. 8. Subject is willing and able to follow all study instructions and to attend all study visits. 9. Subject must be the only individual in a household participating in the study. Exclusion Criteria: 1. Subject has clinically atypical common warts. 2. Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.). 3. Subject has a history of Human Immunodeficiency Virus (HIV) infection. 4. Subject has had any Human Papilloma Virus (HPV) vaccine within 6 months prior to Visit 1. 5. Subject has used any of the following intralesional therapies within the specified period prior to Visit 2: 1. Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks 2. Anti-metabolite therapy (e.g., bleomycin, 5-fluorouracil); 8 weeks 6. Subject has used any of the following systemic therapies within the specified period prior to Visit 2: 1. Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks 2. Glucocorticosteroids (inhaled and intra-nasal steroids are permitted); 28 days 7. Subject has used any of the following topical therapies within the specified period prior to Visit 2 on, or in the proximity to any of the common warts identified for treatment, that in the investigator's opinion interferes with the study medication treatment or the study assessments: 1. LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], photodynamic therapy [PDT]); 180 days 2. Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester[SADBE], etc.) 12 weeks 3. Liquid nitrogen, electrodesiccation, curettage; 60 days 4. Hydrogen peroxide; 90 days 5. Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks 6. Retinoids; 90 days 7. Over-the-counter (OTC) wart therapies and cantharidin; 28 days 8. Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in the proximity to any of the common warts identified for treatment that, in the investigator's opinion, interferes with the study medication treatment or the study assessments: 1. Cutaneous malignancy; 180 days 2. Sunburn; currently 3. Pre-malignancy (e.g., actinic keratosis); currently 9. Subject has a history of sensitivity to any of the ingredients in the study medications. 10. Subject has any current skin or systemic disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations. 11. Participation in another therapeutic investigational drug/device trial in which administration of an investigational treatment occurred with 30 days prior to Visit 1. 12. Subject has an active malignancy. 13. Subjects is viewed by the Principal Investigator as not being able to complete the study.

性别

参与研究的性别:

All

年龄

最小年龄：2 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Aclaris Therapeutics, Inc.

合作者 ^ICMJE

研究员 ^ICMJE

Study Director: Judy Schynder Aclaris Therapeutics

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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