A Phase 2, Multi-center, Double-blind, Randomized, Vehicle-controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects With External Genital Warts and Perianal Warts
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 108
- 试验地点
- 15
- 主要终点
- Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12
研究概览
简要总结
A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts
详细描述
This is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose study to assess safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects with external genital and perianal warts. Eligible subjects will be treated with a topical gel (active or vehicle) for up to 12 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 2 but not more than 20 genital/perianal warts with a maximum total wart surface area no more than 1% body surface area
- •If a woman of child-bearing potential, have a negative pregnancy test and use effective contraception
- •If currently receiving wart treatment, be willing to stop all treatment for 28 days prior to randomization and during the study
排除标准
- •Immunocompromised patients including those with HIV, receiving radiation, or drugs that suppress the immune system
- •Pregnant, planning to become pregnant, or nursing
- •History of cancer (including cervical cancer) within 5 years, with exception of non-melanoma skin cancer in non-genital skin
- •Recent history of other genital skin infections
- •Active HSV and frequent HSV recurrences unless receiving suppression therapy
- •Have hemoglobin < 10 G/dl or methemoglobin > 3%
- •Known allergy to any component of the gel including excipients
- •Previously participated in any study with NVN1000 or SB204
研究组 & 干预措施
NVN1000 8% Gel twice daily
NVN1000 8% Gel twice daily
干预措施: NVN1000 8% Gel (Drug)
NVN1000 8% Gel once daily
NVN1000 8% Gel once daily
干预措施: NVN1000 8% Gel (Drug)
NVN1000 16% Once daily
NVN1000 16% Gel once daily
干预措施: NVN1000 16% (Drug)
Vehicle Gel
Vehicle Gel at frequency to match active
干预措施: Vehicle (Drug)
NVN1000 24% once daily
NVN1000 24% once daily
干预措施: NVN1000 24% (Drug)
结局指标
主要结局
Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12
时间窗: 12 weeks
Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.
次要结局
- Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch(Baseline, Week 2, Week 4, Week 8, Week 12)
- Safety as Determined by Changes in Laboratory Assessments(Baseline, Week 2 and Week 12)
- Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12(12 weeks)
- Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12(12 weeks)