Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata

NCT06430190 | Not Yet Recruiting

• 1 other identifier: Peg IFN α- 2b treatment for CA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Condyloma Acuminatum, Genital Warts, Peginterferon α-2b, Interferon, CO2 Laser

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate

  Week 12

Secondary Outcomes (1)

• Recurrence rate

  Week 24

Other Outcomes (1)

• Adverse events

  from baseline to 24 weeks.

Study Arms (3)

Lesional group

EXPERIMENTAL

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

Systemic group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Other: CO2 laser

Interventions

Peginterferon α-2b injection 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.

Lesional group

CO2 laser 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; Lesional group; Systemic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhangyu Bu: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

CN (1)