Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata

Launched by ZHANGYU BU · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for Condylomata Acuminata, which are growths caused by the human papillomavirus (HPV). The study involves 30 patients who will be randomly placed into three groups to see how well a combination of Peginterferon α-2b and CO2 laser works compared to standard care. The treatment phase will last 12 weeks, followed by 12 weeks of observation to check for any changes or side effects. Researchers will monitor how effective the treatments are, if the growths come back, and if there are any adverse effects.

To participate in this trial, patients need to be between 18 and 65 years old and have specific types of lesions in certain areas of the body. They must also have tested positive for HPV and be willing to sign a consent form. However, pregnant women, those with certain health issues, and individuals who have had recent treatments for genital warts are not eligible. If you join the study, you can expect close monitoring and care from the medical team throughout the trial. This research could help improve treatment options for people with Condylomata Acuminata.

Gender

ALL

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.