NCT05156541

Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts

Open Controlled Randomized Study of the Efficacy and Safety of Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts (Phase III)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: SPP Pharmaclon Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the effectiveness of destructive therapy for anogenital warts in combination with the use of Ingaron in comparison with destructive therapy.

Detailed description

Literature data and the results of preclinical studies of interferon-gamma, as well as the features of HPV immunopathogenesis, show the expediency of studying the use of Ingaron in this pathology. The study was planned to include 50 outpatients of both sexes aged 18 to 50 years with a confirmed diagnosis of anogenital warts. In the course of the study, Ingaron was administered at a dose of 100,000 IU once a day every other day in the period of 10 days. Patients were divided into 2 groups: study and control.

Conditions

• Human Papillomavirus Infection
• Anogenital Warts

Interventions

Type	Name	Description
DRUG	Interferon gamma human recombinant (IFN-G)	received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Timeline

• Start date: 2009-05-18
• Primary completion: 2010-06-30
• Completion: 2010-07-15
• First posted: 2021-12-14
• Last updated: 2021-12-14

Locations

1 site across 1 country: Russia