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Trial Title:
Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata
NCT ID:
NCT06430190
Condition:
Condylomata Acuminata
Conditions: Official terms:
Condylomata Acuminata
Conditions: Keywords:
Condyloma Acuminatum, Genital Warts, Peginterferon α-2b, Interferon, CO2 Laser
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Peginterferon α-2b injection
Description:
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.
Arm group label:
Lesional group
Intervention type:
Drug
Intervention name:
Peginterferon α-2b injection
Description:
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.
Arm group label:
Systemic group
Intervention type:
Other
Intervention name:
CO2 laser
Description:
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.
Arm group label:
Control group
Arm group label:
Lesional group
Arm group label:
Systemic group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hangzhou First People's Hospital
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Contact:
Last name:
Zhangyu Bu
Phone:
0571-56005600
Email:
buzyhz@163.com
Contact backup:
Last name:
Kune Lu
Phone:
0571-56005600
Email:
lke225@zju.edu.cn
Start date:
July 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Zhangyu Bu
Agency class:
Other
Source:
First People's Hospital of Hangzhou
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06430190
