## Protocol Section
### Identification Module
**NCT ID:** NCT06430190

**Brief Title:** 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

#### Organization Study ID Info
**ID:** Peg IFN α- 2b treatment for CA
#### Organization
**Class:** OTHER
**Full Name:** First People's Hospital of Hangzhou
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhangyu Bu

#### Responsible Party

**Investigator Affiliation:** First People's Hospital of Hangzhou

**Investigator Full Name:** Zhangyu Bu

**Investigator Title:** Attending Physician

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Condylomata Acuminata

**Keywords:**

- Condyloma Acuminatum, Genital Warts, Peginterferon α-2b, Interferon, CO2 Laser

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Peginterferon α-2b injection

- Other: CO2 laser

**Label:** Lesional group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Peginterferon α-2b injection

- Other: CO2 laser

**Label:** Systemic group

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Other: CO2 laser

**Label:** Control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lesional group

**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.

**Name:** Peginterferon α-2b injection

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Systemic group

**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.

**Name:** Peginterferon α-2b injection

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Control group

- Lesional group

- Systemic group

**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.

**Name:** CO2 laser

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Measure:** Adverse events

**Time Frame:** from baseline to 24 weeks.

#### Primary Outcomes

**Measure:** Clinical cure rate

**Time Frame:** Week 12

#### Secondary Outcomes

**Measure:** Recurrence rate

**Time Frame:** Week 24

### Eligibility Module

**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.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Email:** buzyhz@163.com

- **Name:** Zhangyu Bu

- **Phone:** 0571-56005600

- **Role:** CONTACT

***Contact 2:***

- **Email:** lke225@zju.edu.cn

- **Name:** Kune Lu

- **Phone:** 0571-56005600

- **Role:** CONTACT

**Country:** China

**Facility:** Hangzhou First People's Hospital

**State:** Zhejiang

**Zip:** 310006

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000014860

- Term: Warts

- ID: D000030361

- Term: Papillomavirus Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000017193

- Term: Skin Diseases, Viral

- ID: D000014412

- Term: Tumor Virus Infections

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000012874

- Term: Skin Diseases, Infectious

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6443

- Name: Condylomata Acuminata

- Relevance: HIGH

- As Found: Condylomata

- ID: M17603

- Name: Warts

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23687

- Name: Papillomavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19501

- Name: Skin Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M17162

- Name: Tumor Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15677

- Name: Skin Diseases, Infectious

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003218

- Term: Condylomata Acuminata

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10407

- Name: Interferons

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
