External Anogenital Warts
Conditions
Keywords
Dietary supplement, Anogenital warts, Viusid, Glizigen
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.
Interventions
DIETARY_SUPPLEMENTGlizigen + 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_SUPPLEMENTPlacebo
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.
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Cuba
Outcome results
None listed