NCT06430190

Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhangyu Bu · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Condylomata Acuminata

Interventions

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

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-01-01
• Completion: 2025-12-01
• First posted: 2024-05-28
• Last updated: 2024-06-20

Locations

1 site across 1 country: China