Condylomata AcuminataNCT06430190
Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata
A study testing Peginterferon α-2b injection and CO2 laser in people with Condylomata Acuminata, run by Zhangyu Bu at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Condylomata Acuminata
- What is being tested?
- Peginterferon α-2b injection and CO2 laser
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Zhangyu Bu, 0571-56005600, buzyhz@163.com
Kune Lu, 0571-56005600, lke225@zju.edu.cn
About this study
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
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.
- Conditions
- Condylomata Acuminata
- Being tested
- Peginterferon α-2b injection, CO2 laser
- Keywords
- Condyloma Acuminatum, Genital Warts, Peginterferon α-2b, Interferon, CO2 Laser
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon α-2b injectionDrug
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.
Peginterferon α-2b injectionDrug
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.
CO2 laserOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lesional group | Experimental | Not described Receives: Drug: Peginterferon α-2b injection; Other: CO2 laser |
| Systemic group | Experimental | Not described Receives: Drug: Peginterferon α-2b injection; Other: CO2 laser |
| Control group | Active comparator | Not described Receives: Other: CO2 laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Measured: Week 12
Secondary outcomes (1)
Recurrence rate
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study startJul 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condylomata AcuminataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhangyu Bu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhangyu Bu, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430190
- Sponsor's protocol ID
- Peg IFN α- 2b treatment for CA
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06430190
- Acronym / sponsor ID
- Peg IFN α- 2b treatment for CA
- Conditions
- Condylomata Acuminata
- Keywords
- Condyloma Acuminatum, Genital Warts, Peginterferon α-2b, Interferon, CO2 Laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhangyu BuUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lesional group | Experimental | Drug: Peginterferon α-2b injection, Other: CO2 laser |
| Systemic group | Experimental | Drug: Peginterferon α-2b injection, Other: CO2 laser |
| Control group | Active comparator | Other: CO2 laser |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon α-2b injectionParticipants 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. | Drug | Lesional group |
| Peginterferon α-2b injectionParticipants 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. | Drug | Systemic group |
| CO2 laserOn 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. | Other | Control group, Lesional group, Systemic group |
Primary outcome
Clinical cure rate
Time frame: Week 12
1 secondary outcome
Recurrence rate
Time frame: Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peginterferon α-2b injection and CO2 laser in people with Condylomata Acuminata, run by Zhangyu Bu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.