Clinical trial NCT06430190: Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Condylomata Acuminata
Keywords: Condyloma Acuminatum, Genital Warts, Peginterferon α-2b, Interferon, CO2 Laser
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical cure rate
timeFrame: Week 12
Secondary outcomes:
measure: Recurrence rate
timeFrame: Week 24
Other outcomes:
measure: Adverse events
timeFrame: from baseline to 24 weeks.
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
References: