Glizigen-Viudid-External Anogenital Warts in Children and Adolescents

External Anogenital Warts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111344
• Other study ID #: CAT-1002-CU
• Status: Completed
• Phase: Phase 3
• First received: April 26, 2010
• Last updated: May 6, 2012
• Start date: December 2010
• Est. completion date: September 2011

Study information

• Verified date: May 2012
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Condylomata Acuminata
• External Anogenital Warts
• Warts

Intervention

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
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.

Locations

Country	Name	City	State
Cuba	Pediatric Hospital "Dr. Juan Manuel Márquez".	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to lesion regression	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.	12 weeks	No
Secondary	Occurrence of adverse effects within the 12 week treatment period		12 weeks	Yes
Secondary	Reduction in the number of lesions	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.	12 weeks	No
Secondary	Lesion aspect	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.	12 weeks	No