Evaluation of the Efficacy of an Intravaginal Treatment With Carboxymethyl-β-glucan and Polycarbophil in the Clearance of High-risk Human Papillomavirus Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in the clearance of high-risk HPV infection in women without cytological alterations upon local treatment with carboxymethyl-β-glucan and polycarbophilon the clearance of high-risk HPV infection in women without cytological alterations.
研究概览
简要总结
These treatments are beta-glucans, polysaccharides of beta-D-glucose that, can influence the clearance of HPV infection. The objective of this study is to evaluate the efficacy of a gel with Carboxymethyl - β -Glucan and polycarbophil when applied intravaginally regarding the clearance of 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. Through the use of adjuvant medical treatments represents a therapeutic strategy to avoid the evasion mechanisms of HPV. One of these most promising treatments is beta-glucans that seem capable of affecting the course of HPV infection.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sexually active women
- •between 30 and 40 years old
- •HR-HPV+ test (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)
- •normal cytology
排除标准
- •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 the clearance of high-risk HPV infection in women without cytological alterations upon local treatment with carboxymethyl-β-glucan and polycarbophilon the clearance of high-risk HPV infection in women without cytological alterations.
时间窗: 24 months (6, 12, 18 and 24 months)
Evaluation of the change in HPV clearance by HPV PCR test
次要结局
- Tolerance assessment: measurement of treatment acceptance by subjects(24 months)
- Change on the incidence of cytological alterations upon local treatment with carboxymethyl - β-glucan and polycarbophil during the follow-up time(24 months (6, 12, 18 and 24 months))
- Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the clearance rate of HPV(24 months (6, 12, 18 and 24 months))
- Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the clearance time of HPV(24 months (6, 12, 18 and 24 months))
- Safety assessment: incidence of Adverse Events(24 months)