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Glizigen-Viudid-External Anogenital Warts in Children and Adolescents

NCT01111344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2012-05-08

No results posted yet for this study

Summary

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.

Conditions

  • External Anogenital Warts

Interventions

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.

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.

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Principal Investigators

  • Edelisa Moredo Romo, MD · Pediatric Hospital "Dr. Juan Manuel Márquez.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Cuba

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 NCT01111344 on ClinicalTrials.gov