Estudio clínico, Aleatorizado, Doble Ciego, Paralelo, Controlado Con Gel de ácido láctico Para Evaluar la Eficacia Del Gel Papilocare® en la reparación de Lesiones Cervicales Causadas Por VPH. A Randomized, Double-blind, Parallel-group, Controlled Clinical Trial Using Lactic Acid Gel to Evaluate the Efficacy of Papilocare® Gel in Repairing Cervical Lesions Caused by HPV.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- cervical mucosal repair
研究概览
简要总结
Clinical Trial phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.
The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or lactic acid gel, using a randomization list and in double-blind conditions.
详细描述
Phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel clinical trial to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.
The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or lactic acid gel, using a randomization list and in double-blind conditions.
The study is divided into 2 parts, the first 100 randomized patients will receive treatment with an administration regimen in both arms: 1 cannula / day for 1 month + 1 cannula on alternate days for 5 months (except for menstruation days). The second part of the study, randomized patients from position 101 to 200, will receive treatment with an administration regimen in both arms: 1 cannula / day for 3 months + 1 cannula on alternate days for 3 months (except the days of menstruation).
Duration of treatment: 6 months Total study duration: 13 months in 5 visits: selection visit, V0 or randomization visit (30 days), V1(Month 3), V2 (Month 6), V3 (Month 12).
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
- Triple (Participant, Care Provider, Investigator)
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 informed consent
- •Accept participation in the study and sign the Informed Consent.
- •Cytological result of ASC-US or LSIL, with concordant colposcopic image, at most 3 months before the selection visit. It is considered concordant with ASCUS and LSIL, a colposcopic result of normality, of non-specific findings or of type 1 changes.
- •Positive HPV according to cobas 4800 technique (high-risk HPV) carried out in a selection visit (or positive available at most 3 months prior to the baseline visit).
- •Women vaccinated and not vaccinated against HPV.
- •Is able, at the discretion of the researcher, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout it.
排除标准
- •Clinically relevant alterations of the immune system or any other autoimmune disease or in treatment with immunosuppressants.
- •Other cytological results other than those provided for in the inclusion criteria.
- •Baseline LSIL biopsies with CIN-
- •Abnormal undiagnosed genital bleeding (during the 6 months prior to the selection visit)
- •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 inclusion of the study.
- •Any planned surgery that precludes correct compliance with the guideline.
- •Use of vaginal contraceptives or other vaginal hormonal treatments.
- •Contraindications to the use of Papilocare® gel or known allergies to any of its components.
- •Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspected pregnancy or breastfeeding.
研究组 & 干预措施
PAPILOCARE
Randomized patients will receive two different guidelines depending on the time of randomization:
- Guideline A (from patient 1 to 100 in order of randomization): guideline of 1 cannula per day x 21 days + 7 days rest during the 1st month + 1 cannula / alternate days until completing 6 months (except for menstruation days ).
- Guideline B (from patient 101 to 200 in order of randomization): pattern of 1 cannula per day x 21 days + 7 days rest for 3 months + 1 cannula / alternate days until completing 6 months (except for menstruation days) .
干预措施: PAPILOCARE (Device)
LACTIC ACID GEL
Randomized patients will receive two different guidelines depending on the time of randomization:
- Guideline A (from patient 1 to 100 in order of randomization): guideline of 1 cannula per day x 21 days + 7 days rest during the 1st month + 1 cannula / alternate days until completing 6 months (except for menstruation days ).
- Guideline B (from patient 101 to 200 in order of randomization): pattern of 1 cannula per day x 21 days + 7 days rest for 3 months + 1 cannula / alternate days until completing 6 months (except for menstruation days) .
干预措施: LACTIC ACID GEL (Device)
结局指标
主要结局
cervical mucosal repair
时间窗: 6 months
Percentage of patients with cervical lesions negativization confirmed be cytology and accordance colposcopy , at 6 months will be used to evaluate the main variables, degree of cervical mucosal repair in HPV-positive women with ASC-US or LSIL.
次要结局
- Percentage of patients with Viral clearance(3 and 6 months.)
- Vaginal health status measured by vaginal health index (VHI)(3 and 6 months.)
- Stress perceived by patients measured by PSS-14 (Perceived Stress Scale 14 items)(3 and 6 months.)
- Safety and tolerability of Papilocare® gel: Record of the incidence, nature and severity of adverse events(6 months)
- Satisfaction degree with Papilocare gel use: Likert type scale(3 and 6 months.)
- Reepithelialization degree of the cervical mucosa(at 3 months)