Glizigen-Viudid-External Anogenital Warts in Children and Adolescents

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: External Anogenital Warts

Treatments: Dietary Supplement: Glizigen + Viusid; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01111344

CAT-1002-CU

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

Glizigen + Viusid

Experimental group

Treatment:

Dietary Supplement: Glizigen + Viusid

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo