Efficacy of Glizigen-Viudid in the Treatment of External Anogenital Warts in Children and Adolescents.
10 Years
18 Years
Both
External Anogenital Warts
Trial Information
Efficacy of Glizigen-Viudid in the Treatment of External Anogenital Warts in Children and Adolescents.
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:
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Time to lesion regression
Outcome Description:
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.
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Edelisa Moredo Romo, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Pediatric Hospital "Dr. Juan Manuel Márquez.
Authority:
Cuba: Institutional Review Board
Study ID:
CAT-1002-CU
NCT ID:
NCT01111344
Start Date:
December 2010
Completion Date:
September 2011
Related Keywords:
- External Anogenital Warts
- Dietary supplement
- Anogenital warts
- Viusid
- Glizigen
- Condylomata Acuminata
- Warts
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