Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata (NCT06430190) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata
China30 participantsStarted 2024-07
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
* …