A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 5
- 主要终点
- Number of participants with complete histologic response
研究概览
简要总结
This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).
详细描述
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.
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)
盲法说明
Double-blind, placebo controlled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women age ≥ 18 years
- •Capable of informed consent
- •Able to collaborate with planned follow-up (transportation, compliance history, etc)
- •Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease. A biopsy diagnosis of vulvar high-grade squamous intraepithelial lesion within the previous 3 months which was not excised or otherwise treated may be accepted for study entry.
- •Positive HPV test at study entry (any genotype).
- •Women of childbearing potential agree to use birth control during the dosing phase (through week 8).
- •Laboratory values at Screening of:
- •Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN)
- •Serum aspartate transaminase (SGOT/AST) < 5 x ULN
- •Serum Bilirubin (total) < 2.5 x ULN
- •Serum Creatinine ≤ 1.5 x ULN
- •Weight ≥ 50kg
排除标准
- •Pregnant and nursing women
- •Concurrent anal, vulvar, or cervical cancer
- •HIV-positive participants with a CD4 count < 200
- •Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen.
- •Unwillingness to undergo an excisional procedure at week 18 to either remove HSIL lesions, or to document histologic regression at a site where HSIL was present at study entry.
- •Currently receiving systemic chemotherapy or radiation therapy for another cancer.
- •Concomitant use of Efavirenz for HIV antiretroviral treatment
- •Concomitant use of strong UGT inhibitors
- •Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration of the study
- •Concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion, Crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen sclerosis or planus, atopic dermatitis, genital atrophy).
- •Concurrent treatment with systemic corticosteroids
研究组 & 干预措施
Artesunate ointment
Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks
干预措施: Artesunate ointment (Drug)
Placebo ointment
Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks
干预措施: Placebo ointment (Drug)
结局指标
主要结局
Number of participants with complete histologic response
时间窗: 18 weeks
Number of participants who have complete histologic response following topical artesunate ointment
次要结局
- Number of participants who have achieved viral clearance(Week 18)
- Number of participants who show partial response(Week 18)
- Number of participants who have durable response(Week 18)
- Incidence of Treatment-Emergent Adverse Events (TEAE)(8 weeks)