Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata

Condylomata Acuminata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430190
• Other study ID #: Peg IFN a- 2b treatment for CA
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Condylomata Acuminata

Intervention

Drug:
• Peginterferon a-2b injection
Participants receive CO2 laser treatment followed by local injection of 36mcg of Peginterferon a-2b directly into the base of each treated wart, repeated weekly for 12 weeks, and then followed for another 12 weeks.
• Peginterferon a-2b injection
Participants undergo CO2 laser treatment and then receive a weekly subcutaneous injection of 180mcg of Peginterferon a-2b for 12 weeks, and then followed for another 12 weeks.

Other:
• CO2 laser
On the day (baseline), CO2 laser treatment was performed to remove all warts, and the treatment range was 0.2cm around the lesion and the depth was up to the dermis. Wound disinfection after laser. Participants are treated with CO2 laser therapy only and are observed for 12 weeks, followed by another 12-week observation period without any additional adjuvant therapy.

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhangyu Bu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		from baseline to 24 weeks.
Primary	Clinical cure rate		Week 12
Secondary	Recurrence rate		Week 24