Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata

Not Applicable

Not yet recruiting

• Conditions: Condylomata Acuminata
• Interventions: Drug: Peginterferon α-2b injection; Other: CO2 laser

• Registration Number: NCT06430190
• Lead Sponsor: Zhangyu Bu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20
• Study Start: 2024-07
• Primary Completion: 2025-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lesional group	Peginterferon α-2b injection	-
Lesional group	CO2 laser	-
Systemic group	Peginterferon α-2b injection	-
Systemic group	CO2 laser	-
Control group	CO2 laser	-

Primary Outcome Measures

Name	Time	Method
Clinical cure rate	Week 12

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	Week 24

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China