Betaglucin 0.2% Versus Imiquimod 5% in Treatment of Ano-genital Warts: Combined Results From Triple Blind Controlled Study

Genital Wart Virus Infection Clinical Trial

— BETAGENWART  

Official title:

Betaglucin 0.2% Gel Versus Imiquimod Cream 5% in the Treatment of Anogenital Warts in 102 Individuals Older Than 18 Years.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03901690
• Other study ID #: 2019-001
• Status: Recruiting
• Phase: Phase 3
• Start date: August 27, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: February 2020
• 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
• Is FDA regulated: No
• Study type: Interventional

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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: May 20, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Condylomata Acuminata
• Genital Wart Virus Infection
• Virus Diseases
• Warts

Intervention

Drug:
• Betaglucin soluble gel 0.2%
With the prior informed consent of the 51 study participants, 5 grams of 0.2% soluble betaglucin gel will be self-applied every 12 hours for 5 days. Both groups will receive an unlabeled tube so that none of the study participants will know what topical treatments they are receiving.
• Imiquimod 5% cream
With the prior informed consent of the 51 study participants, 1 gram of 5% imiquimod will be self-applied once a day for 5 days. Both groups will receive an unlabeled tube so that neither study participant knows what topical treatments they are receiving.

Locations

Country	Name	City	State
Nicaragua	Clínica San Dominic	Managua

Sponsors (3)

Lead Sponsor	Collaborator
Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri	Bioanalisis, CALOX Laboratories

Country where clinical trial is conducted

Nicaragua, 

References & Publications (2)

Baker DA, Ferris DG, Martens MG, Fife KH, Tyring SK, Edwards L, Nelson A, Ault K, Trofatter KF, Liu T, Levy S, Wu J. Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies. Infect Dis Obstet Gynecol. 2011;2011:806105. doi: 10.1155/2011/806105. Epub 2011 Aug 24. — View Citation

Scardamaglia P, Carraro C, Mancino P, Stentella P. [Effectiveness of the treatment with beta-glucan in the HPV-CIN 1 lesions]. Minerva Ginecol. 2010 Oct;62(5):389-93. Italian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure Rate	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.	3 months