Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata

NCT ID: NCT06430190

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-12-31

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.

Conditions

Condylomata Acuminata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lesional group

Group Type: EXPERIMENTAL

Peginterferon α-2b injection

Intervention Type: DRUG

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.

CO2 laser

Intervention Type: OTHER

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.

Systemic group

Group Type: EXPERIMENTAL

Peginterferon α-2b injection

Intervention Type: DRUG

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.

CO2 laser

Intervention Type: OTHER

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.

Control group

Group Type: ACTIVE_COMPARATOR

CO2 laser

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhangyu Bu

OTHER

Sponsor Role: lead

Responsible Party

Zhangyu Bu

Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Countries

China

Facility Contacts

Zhangyu Bu

Role: primary

buzyhz@163.com

0571-56005600

Kune Lu

Role: backup

lke225@zju.edu.cn

0571-56005600

Other Identifiers

Peg IFN α- 2b treatment for CA

Identifier Type: -

Identifier Source: org_study_id