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Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts | Clinical Trials | Clareo Health

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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)

NCT05156541•SPP Pharmaclon Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients of both sexes aged 18 to 50 years with a diagnosis of "Anogenital warts".
•2. The diagnosis "Anogenital warts" was made for the first time at least one year before inclusion in the study.
•3. During the last year prior to inclusion in the study, the patient had at least 2 recurrences of anogenital warts.
•4. The diagnosis is confirmed by the detection of HPV by polymerase chain reaction (PCR).
•5. Negative pregnancy test in women.
•6. Availability of written informed consent to participate in the study.

Exclusion Criteria

•1. Positive test results for syphilis, hepatitis (HbsAg, anti-HCV), HIV infection, gonococcal infection, urogenital trichomoniasis, chlamydial infection, inflammatory diseases of the urogenital system caused by genital mycoplasmas.
•2. Unsystematic use of barrier methods of contraception.
•3. Pregnancy and lactation.
•4. Known allergic reactions to interferons and / or other significant allergic diseases.
•5. Any immunotropic therapy within the last 6 weeks prior to enrollment in the study.
•6. The need to take drugs prohibited during the study.
•7. Condition after organ transplantation, constant intake of immunosuppressive drugs.
•8. Severe pathology from the cardiovascular system (uncontrolled arterial hypertension, unstable angina pectoris, congestive heart failure, cardiac arrhythmias), a history of myocardial infarction or cerebrovascular accident within the last 6 months.
•9. Severe pathology on the part of the liver (increased content of AST, ALT 2 times higher than the upper limit of the norm, the content of total bilirubin\> 2 mg / dL), kidney (content of creatinine\> 1.5 mg / dL); signs of hepatic and / or renal failure.
•10. The presence of severe pathology on the part of the respiratory system, gastrointestinal tract, hematopoietic system.
+3 more criteria

Locations (1)

State scientific center of a dermatovenereology and cosmetology

Moscow, Russia

Key Dates

Start Date

May 18, 2009

Primary Completion Date

June 30, 2010

Completion Date

July 15, 2010

Last Updated

December 14, 2021

Enrollment

ACTUAL participants

Conditions

Human Papillomavirus InfectionAnogenital Warts

Interventions

Interferon gamma human recombinant (IFN-G)

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility Trial of a Multi-level Media Production and Social Marketing Campaign to Reduce HPV Vaccine Hesitancy

Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus

Extended Follow-up of Women Who Received One, Two, and Three Doses of the HPV Vaccine in the Costa Rica Vaccine Trial (CVT), ESCUDDO-CVT Study

Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Asian/Asian American Women Supplement

Prospective Evaluation of Self-Testing to Increase Screening

Transmission of Oncogenic HPV Infection Among Families