Genital Wart Virus InfectionPhase 3BETAGENWARTNCT03901690
Betaglucin 0.2% Versus Imiquimod 5% in Treatment of Ano-genital Warts: Combined Results From Triple Blind Controlled Study
A Phase 3 study testing Betaglucin soluble gel 0.2% and Imiquimod 5% cream in people with Genital Wart Virus Infection, run by Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri at 1 site in Nicaragua.
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%. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Genital Wart Virus Infection
- What is being tested?
- Betaglucin soluble gel 0.2% and Imiquimod 5% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteNicaragua
- Study dates
- 27 Aug 2019to 20 May 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Nicaragua1 site, 1 recruiting
- Recruiting
Clínica San Dominic
Managua, 14027
Alejandro P Perez Fabbri, FACOG ObGyn, 505 86261994, medicoenconsulta27@gmail.com
Helen C Guevara, MSC, 505 8998 8021, guevarad1@yahoo.com
About this study
Official title: Betaglucin 0.2% Gel Versus Imiquimod Cream 5% in the Treatment of Anogenital Warts in 102 Individuals Older Than 18 Years.
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%.
Read the 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.
- Conditions
- Genital Wart Virus Infection
- Being tested
- Betaglucin soluble gel 0.2%, Imiquimod 5% cream
- Keywords
- Betaglucin soluble gel, Ano-genital warts, Clearance, Human papillomavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betaglucin soluble gel 0.2%Drug
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% creamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm Betaglucin | Experimental | 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%. Receives: Drug: Betaglucin soluble gel 0.2% |
| Arm Imiquimod | Active comparator | 51 individuals between the ages of 18 and 50 will receive 5% imiquimod. Receives: Drug: Imiquimod 5% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start27 Aug 2019
- Primary completion10 Mar 2020 (estimated)
- Study completion20 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Genital Wart Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective triple-blind randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
- Sponsor type
- Research network
- Collaborators
- CALOX Laboratories, Bioanalisis
- Responsible party
- Principal investigator, Alejandro Pérez Fabbri MD FACOG, Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
- Investigators
- Romain Fantin, PhD. Math, Study chair, Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901690
- Sponsor's protocol ID
- 2019-001
- Acronym
- BETAGENWART
- Status last verified
- Feb 2020
- First submitted
- 28 Mar 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 21876641Scardamaglia 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.
PubMed 20938424
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betaglucin 0.2% Gel Versus Imiquimod Cream 5% in the Treatment of Anogenital Warts in 102 Individuals Older Than 18 Years.
- ClinicalTrials.gov ID
- NCT03901690
- Acronym / sponsor ID
- BETAGENWART / 2019-001
- Conditions
- Genital Wart Virus Infection
- Keywords
- Betaglucin soluble gel, Ano-genital warts, Clearance, Human papillomavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo FabbriResearch network
- Collaborators
- CALOX Laboratories, Bioanalisis
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 10 Mar 2020 (estimated)
- Study completion
- 20 May 2020 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective triple-blind randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Arm Betaglucin | Experimental | Drug: Betaglucin soluble gel 0.2%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%. |
| Arm Imiquimod | Active comparator | Drug: Imiquimod 5% cream51 individuals between the ages of 18 and 50 will receive 5% imiquimod. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Arm Betaglucin |
| Imiquimod 5% creamWith 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. | Drug | Arm Imiquimod |
Primary outcome
Cure Rate
Time frame: 3 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 21876641Baker 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.
- Results publication: PubMed 20938424Scardamaglia 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain Fantin, PhD. Math study chair
Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Betaglucin soluble gel 0.2% and Imiquimod 5% cream in people with Genital Wart Virus Infection, run by Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri at 1 site in Nicaragua.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nicaragua. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Perez Fabbri, OBGYN (+505 8626-1994, cimif.director.ejecutivo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901690, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.