Glizigen-Viudid-External Anogenital Warts in Children and Adolescents

Phase 3

Completed

• Conditions: External Anogenital Warts
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Glizigen + Viusid

• Registration Number: NCT01111344
• Lead Sponsor: Catalysis SL

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Study Start: 2010-12
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-06
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Glizigen + Viusid	Glizigen + Viusid	-

Primary Outcome Measures

Name	Time	Method
Time to lesion regression	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 Outcome Measures

Name	Time	Method
Occurrence of adverse effects within the 12 week treatment period	12 weeks
Reduction in the number of lesions	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.
Lesion aspect	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.

Trial Locations

Locations (1)

Pediatric Hospital "Dr. Juan Manuel Márquez".; 🇨🇺 Havana, Cuba