NCT01111344

Glizigen-Viudid-External Anogenital Warts in Children and Adolescents

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• External Anogenital Warts

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-04-27
• Last updated: 2012-05-08

Locations

1 site across 1 country: Cuba