Clinical trial NCT03901690: Betaglucin 0.2% Versus Imiquimod 5% in Treatment of Ano-genital Warts: Combined Results From Triple Blind Controlled Study
Official title: Betaglucin 0.2% Gel Versus Imiquimod Cream 5% in the Treatment of Anogenital Warts in 102 Individuals Older Than 18 Years.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Genital Wart Virus Infection
Keywords: Betaglucin soluble gel
Ano-genital warts
Clearance
Human papillomavirus
Lead sponsor: Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
Sponsor class: NETWORK
Collaborators: name: CALOX Laboratories
name: Bioanalisis
First posted: 2019-04-03
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective triple-blind randomized controlled clinical trial
Primary purpose: TREATMENT

Brief 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%.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cure Rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Managua
country: Nicaragua
facility: Clínica San Dominic
Study officials:
affiliation: Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
name: Romain Fantin, PhD. Math
role: STUDY_CHAIR
References:
citation: 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.
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.