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

Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri

Status and phase: Unknown; Phase 3

Conditions: Genital Wart Virus Infection

Treatments: Drug: Betaglucin soluble gel 0.2%; Drug: Imiquimod 5% cream

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT03901690

2019-001

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups

Arm Betaglucin

Experimental group

Description:

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%.

Treatment:

Drug: Betaglucin soluble gel 0.2%

Arm Imiquimod

Active Comparator group

Description:

51 individuals between the ages of 18 and 50 will receive 5% imiquimod.

Treatment:

Drug: Imiquimod 5% cream