Dynamic-I

Intramuscular application of a new freeze-dried formulation of albumin-free recombinant human alpha-2b interferon in Acuminate Condyloma patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000038

Enrollment

Registered

2010-12-20

Start date

2003-04-22

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acuminate Condyloma

Interventions

Group I. One daily intramuscular application of 10x106 UI of the product under study for 2 consecutive days. Group II. One daily intramuscular application of 5x106 UI of the product under study for 4

Interferon-alpha

Interferons

Injections, Intramuscular

recombinant human alpha-2b interferon

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Beta-2 microglobulin level, measuring time: before and after treatment. 2.5 oligoadenylate synthetase level, measuring time: before and after treatment.	—

Secondary

Measure	Time frame
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.	—

Countries

Cuba

Contacts

Public ContactIdrian Garcia Garcia

Biological Researches Center, Clinical Trials Division

idrian.garcia@cigb.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026