Glizigen-Viudid-External Anogenital Warts in Children and Adolescents
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|ClinicalTrials.gov Identifier: NCT01111344|
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : May 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|External Anogenital Warts||Dietary Supplement: Glizigen + Viusid Dietary Supplement: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Glizigen-Viudid in the Treatment of External Anogenital Warts in Children and Adolescents.|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
|Experimental: Glizigen + Viusid||
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).
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 Comparator: Placebo||
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).
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.
- Time to lesion regression [ Time Frame: 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.
- Occurrence of adverse effects within the 12 week treatment period [ Time Frame: 12 weeks ]
- Reduction in the number of lesions [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111344
|Pediatric Hospital "Dr. Juan Manuel Márquez".|
|Havana, Cuba, 10400|
|Principal Investigator:||Edelisa Moredo Romo, MD||Pediatric Hospital "Dr. Juan Manuel Márquez.|