Exploratory, Randomized, Multicenter, Open-Label, Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy of Papilozumib® Vaginal Gel in the Restoration of the Exocervical Mucosa
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 81
- 试验地点
- 6
- 主要终点
- Exocervical mucosal restoration score at Day 30
研究概览
简要总结
This randomized, open-label, multicenter clinical study is designed to evaluate Papilozumib® vaginal gel in women aged 30 to 50 years who test positive for human papillomavirus (HPV) and present with either normal cervical cytology or cytological findings of atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC), accompanied by corresponding colposcopic findings.
Eighty-one participants will be randomly assigned in equal groups to receive either Papilozumib® vaginal gel, Papilozumib® vaginal gel plus an oral supplement, or standard clinical care without study treatment. All participants will be followed for six months.
The primary objective is to assess exocervical mucosa restoration 30 days after treatment initiation using a 5-point colposcopic scale. Additional assessments include cervical cytology, HPV clearance, vaginal health, treatment adherence, satisfaction, tolerability, safety, and exploratory analyses of the vaginal and intestinal microbiota.
详细描述
Persistent human papillomavirus infection may lead to cervical epithelial abnormalities. This exploratory study evaluates whether Papilozumib® vaginal gel helps restore the exocervical mucosa in HPV-positive women with normal, low-grade, or atypical cytological findings.
Eligible participants will be randomly assigned in equal numbers to one of three groups: Papilozumib® vaginal gel, Papilozumib® vaginal gel plus an oral Papilozumib® supplement, or usual clinical practice without study treatment. The study is open-label, with randomization stratified by center.
Participants in the vaginal gel groups will use one single-dose applicator daily for 21 days, followed by 7 days without treatment, during each of the first three months. For the next three months, the gel will be used on alternate days, except during menstrual periods. Those in the combined-treatment group will also take three oral capsules daily for six months.
Assessments will occur at baseline, Day 30, Month 3, and Month 6. The primary outcome is the degree of exocervical mucosal restoration at Day 30, measured by colposcopy on a 5-point scale from severe ectopia and bleeding to no ectopia. Secondary outcomes include changes in colposcopic findings, normalization of cervical cytology, partial or complete HPV clearance by genotyped polymerase chain reaction, vaginal health, adherence, treatment satisfaction, tolerability, and adverse events.
Exploratory assessments will analyze the vaginal microbiota at baseline and Month 6, and the intestinal microbiota at baseline, Month 3, and Month 6, using shotgun metagenomic sequencing.
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
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participant aged 30 to 50 years, inclusive.
- •Able to read and understand the participant information sheet and informed consent form.
- •Willing to participate and able to provide written informed consent.
- •Normal cervical cytology or cervical cytology showing atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC), with corresponding colposcopic findings at baseline.
- •Cervical cytology obtained no more than 3 months before the baseline/randomization visit.
- •Positive test for human papillomavirus (HPV) by polymerase chain reaction (PCR) at baseline.
- •HPV PCR test obtained no more than 3 months before the baseline/randomization visit.
- •Exocervical mucosal restoration score of 3 or lower on the 5-point colposcopic scale at baseline.
- •Baseline colposcopy performed no more than 3 months before randomization; the score may be determined from previously recorded images when available in the medical record.
- •Considered by the investigator able to follow the study instructions, attend the required visits, and complete the study assessments.
排除标准
- •Clinically relevant immune-system disorder, autoimmune disease, or current treatment with immunosuppressive medication.
- •Systemic or local treatment with antibiotics, antifungal agents, or another treatment that may alter the microbiota within 4 weeks before baseline/randomization.
- •Undiagnosed abnormal genital bleeding during the 6 months before screening.
- •Symptomatic vulvovaginal infection.
- •Surgical cervical excision within the previous year, cervical conization within the previous 6 months, or previous total hysterectomy.
- •Previous gynecological cancer.
- •Current participation in another clinical study or participation in another clinical study within 4 weeks before screening.
- •Planned surgery that could prevent adherence to the study treatment schedule.
- •Use of vaginal contraceptives or other vaginal hormonal treatments.
- •Contraindication to the vaginal gel or known allergy to any of its components.
- •Pregnant, suspected to be pregnant, breastfeeding, or of childbearing potential and not using an effective contraceptive method.
研究组 & 干预措施
Papilozumib vaginal gel
Participants receive Papilozumib® vaginal gel for 6 months. During the first 3 months, one single-dose vaginal applicator is administered daily for 21 days followed by 7 days without treatment. During the following 3 months, one applicator is administered on alternate days, excluding menstrual periods
干预措施: Papilozumib vaginal gel (Device)
Papilozumib vaginal gel plus oral supplement
Participants receive Papilozumib® vaginal gel for 6 months using the same regimen as the vaginal-gel-only arm. Participants also receive oral Papilozumib® for 6 months, administered as two capsules while fasting and one capsule before dinner each day, separated from meals.
干预措施: Papilozumib vaginal gel (Device)
Papilozumib vaginal gel plus oral supplement
Participants receive Papilozumib® vaginal gel for 6 months using the same regimen as the vaginal-gel-only arm. Participants also receive oral Papilozumib® for 6 months, administered as two capsules while fasting and one capsule before dinner each day, separated from meals.
干预措施: Papilozumib oral supplement (Dietary Supplement)
Usual clinical practice without study treatment
Participants receive usual clinical practice without Papilozumib® vaginal gel or oral Papilozumib® supplementation. Participants undergo the study assessments and follow-up procedures specified in the protocol.
结局指标
主要结局
Exocervical mucosal restoration score at Day 30
时间窗: Day 30 after treatment initiation
Exocervical mucosal restoration will be assessed by colposcopy in participants assigned to Papilozumib® vaginal gel alone. The investigator will score the exocervical mucosa using a 5-point scale: 1, severe ectopia with bleeding; 2, severe or extensive ectopia involving more than 50% from the external cervical opening; 3, moderate ectopia involving 25% to 50%; 4, mild ectopia involving less than 25%; and 5, no ectopia. Higher scores indicate greater exocervical mucosal restoration.
Participants with concordant cytology and colposcopy at Day 30
时间窗: Day 30 after treatment initiation
In participants assigned to Papilozumib® vaginal gel alone, the investigator will record whether the cervical cytology result is concordant with the colposcopic finding using a "Yes" or "No" response. The outcome will be reported as the percentage of participants with concordant findings.
次要结局
- Exocervical mucosal restoration score at follow-up visits(Day 30 for Arms B and C; Month 3 and Month 6 for all arms)
- Percentage of participants with concordant cytology and colposcopy findings(Day 30 for Arms B and C; Month 3 and Month 6 for all arms)
- Percentage of participants with normalization of abnormal cervical cytology(Day 30, Month 3, and Month 6)
- Percentage of participants with complete Human Papillomavirus Virus clearance(Month 6)
- Percentage of participants with partial Human Papillomavirus Virus clearance(Month 6)
- Change from baseline in Vaginal Health Index score(Baseline, Day 30, Month 3, and Month 6)
- Participant-reported treatment satisfaction score(Day 30, Month 3, and Month 6)
- Percentage of participants by vaginal gel adherence category(Day 30, Month 3, and Month 6)
- Percentage of participants by oral supplement adherence category(Day 30, Month 3, and Month 6)
- Number of participants with at least one adverse event(From randomization through Month 6)
- Participant-reported treatment tolerability score(Day 30, Month 3, and Month 6)