Betaglucin 0.2% Gel Versus Imiquimod Cream 5% in the Treatment of Anogenital Warts in 102 Individuals Older Than 18 Years.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Cure Rate
研究概览
简要总结
In order to determine the Efficacy of Betaglucin 0.2% in gel vs Imiquimod 5% cream in the treatment of 102 individuals older than 18 years with anogenital warts trials in two arms 51 with Betaglucin 0.2% and 51 with Imiquimod 5%.
详细描述
Betaglucin soluble gel at 0.2% is produced in Costa Rica by a biochemical researcher. Obtained by chemical process improves the immune response by increasing 80 times the number of macrophages and Natural Killer cells. Specifically in human papillomavirus-related anogenital warts.
As clinical researchers, the investigators pretend to determine the therapeutic efficacy of betaglucin 0.2 % gel compared with Imiquimod 5% cream in two groups of individuals from 18 to 50 years old males and females.
Based in mathematics and biostatistics formula used by Professor Roman Fentin, French academic working in the University of Costa Rica. Medicine Faculty in San Jose the number of participants should be 102.
Divided into two arms. Arm betaglucin 0.2% 51 individuals treated with betaglucin soluble gel at 0.2% Arm imiquimod 5% 51 individuals treated with imiquimod cream at 5 % After three months of follow-up of all individuals, will be classified as clearance, partially cured and not cured.
The plan of analysis will be:
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, Investigator, Outcomes Assessor)
盲法说明
In this clinical trial, the masking is triple because neither the participants nor the researchers nor the outcomes assessor will know exactly which drug will receive.
Only through a list created mathematically by Prof R Fentin will serve as a unique guide for the administration masked either beta-glucan gel or imiquimod in cream. Both packaged in the same tube without labeling on the outside.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 50 years with anogenital wart visible on physical examination and positive for HPV 6 and 11 by polymerase chain reaction (PCR) test with detection by agarose gel electrophoresis.
排除标准
- •Pregnant women.
- •Vaccinated against human papillomavirus (Gardasil, Gardasil 9 or Cervarix).
- •Patients Immunosuppressed by drugs (Chemotherapy, Corticoids, use of antibiotics for more than 7 days and/or antituberculous treatment.)
- •Molluscum contagiosum.
- •Skin Appendages.
- •Urethral prolapse.
- •Botryoid sarcoma.
- •Herpes type II.
- •History of anogenital surgery in the last 4 weeks.
- •Intake of natural products or immunomodulators.
- •Patients who have received 5% imiquimod cream.
研究组 & 干预措施
Arm Betaglucin
It will be composed of 51 individuals between 18 and 50 years old with anogenital warts to which will be applied betaglucin gel at 0.2%.
干预措施: Betaglucin soluble gel 0.2% (Drug)
Arm Imiquimod
51 individuals between the ages of 18 and 50 will receive 5% imiquimod.
干预措施: Imiquimod 5% cream (Drug)
结局指标
主要结局
Cure Rate
时间窗: 3 months
Completely cured will be those that present a disappearance of 80% or more of the initial volume of the wart, partially cured will be a decrease of at least 50%-79% of the initial volume of the lesion using a measurement rule applied to the larger diameter of this and not cured those that present a reduction of less than 50% of the initial volume.
次要结局
未报告次要终点
研究者
Alejandro Pérez Fabbri MD FACOG
Doctor in Medicine. Executive Director CIMIF
Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri