Dynamic-I

Phase 2

• Conditions: Condylomata Acuminata; Skin Diseases, Infectious; DNA Virus Infections; Sexually Transmitted Diseases; Skin Diseases; Acuminate Condyloma; Tumor Virus Infections; Sexually Transmitted Diseases, Viral; Skin Diseases, Viral; Warts

• Registration Number: RPCEC00000038
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Clinical and histological diagnosis positive to Acuminate Condyloma by papilloma virus. Patients of both sexes with Acuminate Condyloma lesions in external genitals, perianal region, and inner thighs. Patients aged 18 to 60. No topical or systemic treatment with IFN or any other antiviral drug one month before inclusion in the study. Reproductive-age women using any non-hormonal contraceptive. Patient’s consent in writing to participate in the study.

Exclusion Criteria

Other sexually transmitted diseases (syphilis, infectious urethritis, AIDS). Antiviral or immunosuppressor (corticosteroid, cytostatic) therapy three months before commencing INF treatment. Severe systemic and chronic diseases affecting the patient’s general condition and modifying therapeutic response, including malignant neoplasias and immunodeficiency. Lesion sepsis demanding systemic antibiotic treatment. Pregnancy or breastfeeding. Patients with history of hypersensitivity to alpha INF or any formulation component.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Beta-2 microglobulin level, measuring time: before and after treatment. 2.5 oligoadenylate synthetase level, measuring time: before and after treatment.

Secondary Outcome Measures

Name	Time	Method
Size of lesions (greater and lesser diameters), measuring time: before and after treatment. Number of lesions, measuring time: before and after treatment. Need for other conventional treatments, measuring time: before and after treatment.