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Clinical Trial Summary

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%.


Clinical Trial Description

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:

- Chi-square test between the two groups (depending on the treatment) and the success or not of the treatment.

- Logistic model with a dependent variable the success or not of the treatment and with independent variables the treatment, sex, age. It will make it possible to verify that the differences observed in 1 are not due to another factor.

- Logistic model with a dependent variable the success or not of the treatment and with independent variables the treatment, the sex, the age, and an interaction sex-age. It will allow us to observe if there is a difference in the result according to the patient's sex. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03901690
Study type Interventional
Source Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
Contact Alejandro Perez Fabbri, OBGYN
Phone +505 8626-1994
Email cimif.director.ejecutivo@gmail.com
Status Recruiting
Phase Phase 3
Start date August 27, 2019
Completion date May 20, 2020