Clinical trial NCT05156541: Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts
Official title: Open Controlled Randomized Study of the Efficacy and Safety of Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts (Phase III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Papillomavirus Infection
Anogenital Warts
Keywords: interferon gamma
IFN-g
HPV
Anogenital warts
Lead sponsor: SPP Pharmaclon Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.
11. Other serious (acute or chronic) pathological conditions, including mental illness, as well as abnormalities in laboratory parameters, which, in the opinion of the investigator, may increase the risk associated with participation in the study or affect the interpretation of efficacy and safety data obtained in this research.
12. Alcohol and / or drug dependence.
13. Participation in other clinical trials in the last three months prior to inclusion.

Primary outcomes:
measure: Recurrence of anogenital warts
timeFrame: Day 11
measure: Recurrence of anogenital warts
timeFrame: Day 40
measure: Recurrence of anogenital warts
timeFrame: Day 100
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State scientific center of a dermatovenereology and cosmetology
Study officials:
affiliation: SPP Pharmaclon Ltd.
name: Leonid Apanansky, Master
role: STUDY_DIRECTOR
References: