Betaglucin 0.2% Versus Imiquimod 5% in Treatment of Ano-genital Warts: Combined Results From Triple Blind Controlled Study
NCT ID: NCT03901690
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
102 participants
INTERVENTIONAL
2019-08-27
2020-05-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Study Groups
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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%.
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.
Arm Imiquimod
51 individuals between the ages of 18 and 50 will receive 5% imiquimod.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
No
Sponsors
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CALOX Laboratories
UNKNOWN
Bioanalisis
UNKNOWN
Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
NETWORK
Responsible Party
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Alejandro Pérez Fabbri MD FACOG
Doctor in Medicine. Executive Director CIMIF
Principal Investigators
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Romain Fantin, PhD. Math
Role: STUDY_CHAIR
Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
Locations
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Clínica San Dominic
Managua, , Nicaragua
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2019-001
Identifier Type: -
Identifier Source: org_study_id
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