Glizigen-Viudid-External Anogenital Warts in Children and Adolescents

May 6, 2012 updated by: Catalysis SL

Efficacy of Glizigen-Viudid in the Treatment of External Anogenital Warts in Children and Adolescents.

The purpose of the study is to assess the efficacy of Glizigen and Viusid administration in the treatment of external anogenital warts in children and adolescents. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 76. Variables to be assessed will be: time to disappearance of lesions, reduction of the number of lesions and change in the aspect of lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
      • Havana, Cuba, 10400
        • Pediatric Hospital "Dr. Juan Manuel Márquez".

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No previous treatment for anogenital warts
  • Negative serology for HB and HIV.
  • Signed informed consent.

Exclusion Criteria:

  • Pregnancy
  • Treatment with steroids, immune-suppressors, immune-modulators or local or systemic antiviral drugs.
  • Hypersensitivity to Glizigen or Viusid:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo

Placebo Glizipen (spray, 60 mL bottle with applicator): Dosage commensurate with surface (up to a maximum of 10 cm2) to be treated. From 3 to 5 ambulatory applications (One nebulization corresponds to 2 short pulses).

  • 1 to 3.9 cm2 ______________3 daily applications
  • 4 to 6.9 cm2 ______________4 daily applications
  • 7 to 10 cm2 ______________5 daily applications Treatment will last from 5 days to 8 weeks according to clinical improvement.

Placebo Viusid (Syrop, 500 mL flask): 12.5 ml every 8 hours for 12 weeks. Viusid syrop should be dissolved in water, fruit juice or milk before ingestion.
Experimental: Glizigen + Viusid
Dietary supplement: Glizigen + Viusid

Glizigen (spray, 60 mL bottle with applicator): Dosage commensurate with surface (up to a maximum of 10 cm2) to be treated. From 3 to 5 ambulatory applications (One nebulization corresponds to 2 short pulses).

  • 1 to 3.9 cm2 ______________3 daily applications
  • 4 to 6.9 cm2 ______________4 daily applications
  • 7 to 10 cm2 ______________5 daily applications Treatment will last from 5 days to 8 weeks according to clinical improvement.

Viusid (Syrop, 500 mL flask): 12.5 ml every 8 hours for 12 weeks. Viusid syrop should be dissolved in water, fruit juice or milk before ingestion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to lesion regression
Time Frame: 12 weeks
Excellent: Lesion regression before 2 weeks of treatment Good: Lesion regression between 2-5 weeks of treatment Poor: Lesion regression between 5-8 weeks of treatment Bad: No lesion regression after 8 weeks of treatment.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of adverse effects within the 12 week treatment period
Time Frame: 12 weeks
12 weeks
Reduction in the number of lesions
Time Frame: 12 weeks
Excellent: Regression in more than 75% of lesions Good: Regression in 50-75% of lesions Poor: Regression in 25-50% of lesions Bad: Regression in less than 25% of lesions.
12 weeks
Lesion aspect
Time Frame: 12 weeks
Excellent: Lesion regression Poor: Aspect changes from papilloma shaped to flat shaped lesion. Bad: No change in aspect or change from flat shaped to papilloma shaped lesion.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Edelisa Moredo Romo, MD, Pediatric Hospital "Dr. Juan Manuel Márquez.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 6, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-1002-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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