A Prospective, Exploratory Study to Evaluate the Efficacy of Peginterferon α-2b Injection Combined With Carbon Dioxide(CO2) Laser in the Treatment of Condylomata Acuminata

Peg IFN α- 2b treatment for CA

This is a prospective, randomized, open-label, controlled study, aiming to enroll 30 patients with Condylomata Acuminata. The study consists of two phases: a treatment phase (Weeks W1-W12) and an observation phase (Weeks W13-W24). Eligible patients will be randomly allocated into three groups at a ratio of 1:1:1: Test Group 1, Test Group 2, or the Control Group. And clinical cure, recurrence rates, adverse events, vital signs, laboratory tests, drug exposure doses, premature withdrawals will be analyzed.

2024-05-01

2025-01-01

2025-12-01

Not yet recruiting

30

Inclusion Criteria: * Patients must be between 18 and 65 years old. * Patients with positive of human papillomavirus(HPV) nucleic acid test and acetowhite test, were diagnosed as condyloma acuminatum according to clinical manifestations and epidemiological history. * Patients' lesions are located on non-cavity areas such as the foreskin, glans penis, labia majora, labia minora, with a number ranging from 1 to 5 individual lesions, and each individual lesion having a diameter less than 1 centimeter. * For female participants with reproductive capability, a negative pregnancy test result is mandatory at the screening stage. * Participants must volunteer to enroll in the study and be able to understand and sign a written informed consent form. Exclusion Criteria: * Pregnant women, breastfeeding mothers, or individuals planning to conceive during the study period. * Patients who received treatment for genital warts within two weeks prior to screening. * Patients with concurrent skin conditions in the affected area that might significantly impact the evaluation of treatment efficacy. * Individuals with known severe immunodeficiency or those requiring long-term use of corticosteroids and immunosuppressive agents. * Active carriers of hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), or Treponema pallidum (syphilis). * Patients with a history of severe cardiovascular, hepatic, renal, endocrine, digestive, immune, respiratory, or nervous system diseases. * Patients with severe retinal disorders or other serious ophthalmologic conditions. * Patients allergic to interferons or excipients in the medication formulation, or those deemed unsuitable for CO2 laser treatment. * Individuals meeting any contraindications listed in the investigational drug's package insert. * Patients who participated in another interventional clinical trial within three months before screening, or those planning to participate in another clinical trial during the study period. * Other cases deemed inappropriate for enrollment by the investigator due to various reasons.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-05-28