Ensayo clínico, Aleatorizado, Abierto, de Grupos Paralelos y Con Grupo Control, Para Explorar la Eficacia Del Gel PAPILOCARE en la reparación de la Mucosa cérvico-vaginal Con Lesiones Causadas Por VPH (Ensayo Clínico PALOMA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 18
- 主要终点
- Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
研究概览
简要总结
Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1).
详细描述
Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (usual clinical practice -without treatment-). Selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment. Patients will visit the site into a total of 5 visits throughout the study.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman between the ages of 30 and 65 (both included).
- •Able to read and understand the Patient Information Sheet and the Informed Consent form.
- •Accept participation in the study and sign the Informed Consent form.
- •Cytological result of ASC-US or LSIL or AG-US, with matching colposcopic image, maximum 3 months before the screening visit.
- •Positive HPV by PCR performed at the screening visit (or positive available at most 3 months prior to the baseline visit).
- •Is capable, at the discretion of the investigator, of complying with the requirements of the study protocol and without impediments to follow the instructions and evaluations throughout it.
排除标准
- •Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
- •Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
- •To had been vaccinated against HPV.
- •Other symptomatic vulvovaginal infections.
- •Surgical cervical excision in the last year or total hysterectomy.
- •Previous history of gynecological cancer.
- •Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the study.
- •Any planned surgery that prevents the correct compliance with the protocol.
- •Use of vaginal contraceptives or other vaginal hormonal treatments.
- •Contraindications for Papilocare gel use or known allergies to any of its components.
- •Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.
结局指标
主要结局
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
时间窗: 6 months
Evaluate the repairment of the cervico-vaginal mucosa in positive HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image, 6 months after the start of treatment.
次要结局
- Satisfaction of papilocare gel use measured by likert scale.(3 and 6 months)
- Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image(3 and 12 months)
- Vaginal health status measured by Bachmann Index.(3,6 and 12 months)
- Reeptielization of the cervico-vaginal mucosa measured by a likert scale.(3,6 and 12 months)
- Therapeutic compliance(3 and 6 months)