Glizigen-Viudid-External Anogenital Warts in Children and Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01111344
First received: April 26, 2010
Last updated: May 6, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
External Anogenital Warts
Dietary Supplement: Glizigen + Viusid
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Glizigen-Viudid in the Treatment of External Anogenital Warts in Children and Adolescents.

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • Time to lesion regression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Occurrence of adverse effects within the 12 week treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Reduction in the number of lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Lesion aspect [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 76
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111344

Locations
Cuba
Pediatric Hospital "Dr. Juan Manuel Márquez".
Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Edelisa Moredo Romo, MD Pediatric Hospital "Dr. Juan Manuel Márquez.
  More Information

No publications provided

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT01111344     History of Changes
Other Study ID Numbers: CAT-1002-CU
Study First Received: April 26, 2010
Last Updated: May 6, 2012
Health Authority: Cuba: Institutional Review Board

Keywords provided by Catalysis SL:
Dietary supplement
Anogenital warts
Viusid
Glizigen

Additional relevant MeSH terms:
Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on September 18, 2014