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

NCT03901690 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-02-05

No results posted yet for this study

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%.

Conditions

  • Genital Wart Virus Infection

Interventions

DRUG

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

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.

Sponsors & Collaborators

  • CALOX Laboratories

    collaborator UNKNOWN

  • Bioanalisis

    collaborator UNKNOWN

  • Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri

    lead NETWORK

Principal Investigators

  • Romain Fantin, PhD. Math · Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2020-03-10
Completion
2020-05-20

Countries

  • Nicaragua

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03901690 on ClinicalTrials.gov