Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata

Zhangyu Bu

Status: Not yet enrolling

Conditions: Condylomata Acuminata

Treatments: Other: CO2 laser; Drug: Peginterferon α-2b injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06430190

Peg IFN α- 2b treatment for CA

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Lesional group

Experimental group

Treatment:

Drug: Peginterferon α-2b injection

Other: CO2 laser

Drug: Peginterferon α-2b injection

Systemic group

Experimental group

Treatment:

Drug: Peginterferon α-2b injection

Other: CO2 laser

Drug: Peginterferon α-2b injection

Control group

Active Comparator group

Treatment:

Other: CO2 laser