Betaglucin 0.2% Versus Imiquimod 5% in Treatment of Ano-genital Warts: Combined Results From Triple Blind Controlled Study
BETAGENWART
Betaglucin 0.2% Gel Versus Imiquimod Cream 5% in the Treatment of Anogenital Warts in 102 Individuals Older Than 18 Years.
1 other identifier
interventional
102
1 country
1
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2019
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedStudy Start
First participant enrolled
August 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2020
CompletedFebruary 5, 2020
February 1, 2020
7 months
March 28, 2019
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Arm Betaglucin
EXPERIMENTALIt 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%.
Arm Imiquimod
ACTIVE COMPARATOR51 individuals between the ages of 18 and 50 will receive 5% imiquimod.
Interventions
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.
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbrilead
- CALOX Laboratoriescollaborator
- Bioanalisiscollaborator
Study Sites (1)
ClĂnica San Dominic
Managua, 14027, Nicaragua
Related 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.
PMID: 21876641BACKGROUNDScardamaglia 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.
PMID: 20938424RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Romain Fantin, PhD. Math
Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- In this clinical trial, the masking is triple because neither the participants nor the researchers nor the outcomes assessor will know exactly which drug will receive. 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor in Medicine. Executive Director CIMIF
Study Record Dates
First Submitted
March 28, 2019
First Posted
April 3, 2019
Study Start
August 27, 2019
Primary Completion
March 10, 2020
Study Completion
May 20, 2020
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Available on May 2019 until May 2021
- Access Criteria
- Available for clinical researchers, professors and health care providers
There is a timeline that includes a start date, end date, informed consent signature, study protocol, statistical analysis plan, informed consent form, clinical study report.