Protocol 250-1951-201: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of VDMN-21 in Subjects With Verruca Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 16
- 主要终点
- Proportion of subjects with complete clinical resolution of the Target Lesion at end of treatment period
研究概览
简要总结
This Phase 2 study has been designed to determine the safety and efficacy of repeated treatment sessions of VDMN-21 patch at two dose strengths as compared to a matched vehicle control patch in subjects with verruca vulgaris
详细描述
Protocol 250-12951-201 is a planned Phase 2 study entitled "A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of VDMN-21 in Subjects with Verruca Vulgaris". Eligible subjects will be randomized into one of the three treatment groups (high dose, low dose, vehicle).
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)
入排标准
- 年龄范围
- 9 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a male or non-pregnant female, 9 to 65 years of age.
- •Subject has provided written informed consent/assent.
- •Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Baseline.
- •Subject has at least 1 and up to 8 common warts (verruca vulgaris),
- •Subject is willing to undergo test article therapy as directed, comply with study instructions (including availability to a smart phone or equivalent device for telehealth visit requirements), and commit to all follow-up visits for the duration of the study.
- •Subject is in good general health and free of any disease state or physical condition that might impair evaluation of the identified warts and/or treatment area or exposes the subject to an unacceptable risk by study participation.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject used or will use oral zinc and/or cimetidine within 30 days prior to enrollment or during the course of the study.
- •Subject has received 3 or more prior treatments to the Target Lesion without resolution.
- •Subject received any of the following therapies within the specified wash-out period prior to Baseline in the treatment area of the Target Lesion
- •LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], PDT; 12 weeks
- •Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester [SADBE], etc.), retinoids, hydrogen peroxide; 12 weeks
- •Cryotherapy, biopsy, electrodessication, curettage, antimetabolite therapy (e.g., 5- fluorouracil), cantharidin, or any other treatment that in the opinion of the Investigator may affect the Target Lesion; 6 weeks
- •Over-the-counter (OTC) wart therapies, paring ± occlusion; 1 week
- •Subject has scars, tattoos, or other features that may interfere with the evaluation of the Target Lesion, in the opinion in the investigator.
- •Subject has a significant autoimmune condition or is immunocompromised based on their medical condition (e.g., HIV, malignancy, etc.), medication use, or other factors. Routine use of inhaled, intranasal or ophthalmologic corticosteroids during the study is allowed.
- •Subject has received systemic immunosuppressive therapy such as steroids, methotrexate, cyclosporine, tacrolimus, chemotherapy, etc. within in 4 weeks prior to Baseline.
- •Subject has any active malignancy or are undergoing treatment for any malignancy other than nonmelanoma skin cancer;
- •Subject has history of significant ophthalmologic inflammatory disease, including uveitis.
- •Subject is currently enrolled in an investigational drug, biologic, or device study.
- •Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 1/Baseline.
- •Subject has a history of allergy or sensitivity to this antigen extract or similar products.
研究组 & 干预措施
Treatment Group A (Low Dose)
Low does patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month).
干预措施: VDMN-21 Patch Low Dose (Drug)
Treatment Group B (High Dose)
High does patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month).
干预措施: VDMN-21 Patch High Dose (Drug)
Treatment Group C (Vehicle)
Vehicle patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month).
干预措施: Vehicle Patch (Drug)
结局指标
主要结局
Proportion of subjects with complete clinical resolution of the Target Lesion at end of treatment period
时间窗: Baseline up to Day 134
Complete clinical resolution is defined as the target lesion with area = 0.
次要结局
未报告次要终点