Evaluation of the Efficacy of an Intravaginal Treatment With Carboxymethyl-β-glucan and Polycarbophil on the Regression of Low-grade Cervical Intraepithelial Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Change in CIN1 regression rate
研究概览
简要总结
A therapeutic strategy to neutralize the evasion mechanisms of HPV. Among these treatments are beta-glucans, polysaccharides of beta-D-glucose that, can influence the clearance of HPV. The objective of this study is to evaluate the efficacy of a gel with Carboxymethyl - β -Glucan and polycarbophil when applied intravaginally, on the regression of low-grade cervical intraepithelial lesions (CIN) associated to HR-HPV infection.
详细描述
Background
Human papillomavirus (HPV) infection represents a significant source of morbidity and mortality worldwide. High-risk oncogenic HPVs cause 99.7% of cervical cancers. 80% of sexually active women will be infected with HPV at some point in their life. Most of these infections are transitory and only if they are persistent and caused by a high-risk oncogenic HPV are they an important risk factor for the development of cervical intraepithelial lesions and invasive cervical cancer. Immunity plays a key factor in eliminating HPV infection. The innate immune response constitutes the first line of defense against infection during the early stages of infection, promoting a cytokine-mediated inflammatory response which links innate immunity with the adaptive immune response. HPV evasion of these immune defense mechanisms is critical for the persistence of the infection and leads to the development of preneoplastic lesions and ultimately to cervical cancer. One of most promising treatments is beta-glucans that seem capable of affecting the course of HPV infection, and consequently, the progression of its associated intraepithelial lesions.
Justification
β-glucans are a very diverse heterogeneous group of polysaccharides made up of D-glucose monomers linked by β-type glycosidic bonds.
β-glucans have been previously described in bacteria, fungi, yeasts (including brewer's yeast), plants and algae, where they play an important structural role in the cell wall or reservoir.
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
- •Woman between 30 and 50 years old
- •Capable of understanding the Pacient Information Sheet and the Informed Consent form
- •Accepting her particpation in the study and signing the Informed Consent
- •LSIL/CIN1 hystological result on cervical biopsy preceeded by HR-HPV+ test (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)
- •Cervical cytology ≥ ASCUS or precceded by a HPV16+ test and negative cervical cytology for lesion or malignancy but with CIN1 colposcopy and biopsy.
排除标准
- •Cervical cytology suspicious of invasive cervical cancer
- •Current or previous pregnancy ended before six weeks in relation to the start of the study.
- •Vaccination against HPV.
- •Clinically relevant pathology linked to immunodeficiency.
- •Immunosuppressive treatment active or finished before six months in relation to the start of the study. In the specific case of corticosteroids, all women who are receiving corticosteroid treatment currently or recently (defined as the two weeks prior to the start of the study) or if she has received 2 or more cycles of corticosteroids in equal or greater than 20 mg / day of predsinone (or equivalent) orally or parenterally, for one week duration at least in the year prior to the start of the study. The use of inhaled corticosteroids, Nasal or topical are not exclusion criteria.
- •Undiagnosed abnormal genital bleeding.
- •Total hysterectomy.
- •Presence of genital warts and other symptomatic vulvovaginal infections.
- •Documented history of cervical pathology caused by HPV.
- •Current systemic and / or gynecological disease that contraindicates the use of Colpofix.
- •Contraindications to the use of Colpofix or known allergies to any of its components
- •Simultaneous participating in a clinical study of an investigational drug or that could interfere with the use of Colpofix.
结局指标
主要结局
Change in CIN1 regression rate
时间窗: 24 months (6, 12, 18 and 24 months)
CIN evaluation by biopsy
次要结局
- Normalization rate of abnormal colposcopy(24 months (6, 12, 18 and 24 months))
- Normalization time of abnormal cytology(24 months (6, 12, 18 and 24 months))
- HPV clearance rate(24 months (6, 12, 18 and 24 months))
- CIN1 lesion regression or clearance time(24 months (6, 12, 18 and 24 months))
- Progression to CIN2+ rate(24 months (6, 12, 18 and 24 months))
- HPV clearance time(24 months (6, 12, 18 and 24 months))
- Normalization rate of abnormal cytology(24 months (6, 12, 18 and 24 months))
- Normalization time of abnormal colposcopy(24 months (6, 12, 18 and 24 months))