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Not yet recruitingNCT06430190Updated Jun 20, 2024

Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata

An interventional study of Peginterferon α-2b injection and Peginterferon α-2b injection in Condylomata Acuminata, sponsored by Zhangyu Bu. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by Zhangyu Bu · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Condylomata Acuminata

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Keywords

  • Condyloma Acuminatum, Genital Warts, Peginterferon α-2b, Interferon, CO2 Laser
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Lesional group

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

  • Experimental
    Systemic group

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

  • Active comparator
    Control group

    Other: CO2 laser

Interventions

  • DrugPeginterferon 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.

  • DrugPeginterferon 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.

  • OtherCO2 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.

05

What researchers measure

Primary outcomes

  1. Clinical cure rate

    Time frame: Week 12

Secondary outcomes

  1. Recurrence rate

    Time frame: Week 24

Other outcomes

  1. Adverse events

    Time frame: from baseline to 24 weeks.

06

Study locations

1 site
  • Hangzhou First People's Hospital
    Hangzhou, Zhejiang 310006, China
07

Registry details

Key details

Study ID
NCT06430190
Lead sponsor
Zhangyu Bu
Responsible party
Zhangyu Bu (Attending Physician, First People's Hospital of Hangzhou) — Sponsor-investigator
First posted
May 28, 2024
Start date
Jul 2024 (estimated)
Primary completion
Jan 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jun 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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