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NCT Number: NCT01111344

Glizigen-Viudid-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.

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Key information

Conditions

External Anogenital Warts Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pediatric Hospital "Dr. Juan Manuel Márquez".

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

Treatment and study plan

Glizigen + Viusid

Dietary Supplement

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.

Placebo

Dietary Supplement

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Occurrence of adverse effects within the 12 week treatment period

    Time frame: 12 weeks

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2010
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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