Glizigen-Viudid-External Anogenital Warts in Children and Adolescents

NCT ID: NCT01111344

Last Updated: 2012-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-09-30

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.

Conditions

External Anogenital Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Glizigen + Viusid

Group Type: EXPERIMENTAL

Glizigen + Viusid

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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:

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catalysis SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edelisa Moredo Romo, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Hospital "Dr. Juan Manuel Márquez.

Locations

Pediatric Hospital "Dr. Juan Manuel Márquez".

Havana, La Habana, Cuba

Countries

Cuba

Other Identifiers

CAT-1002-CU

Identifier Type: -

Identifier Source: org_study_id