Betaglucin 0.2% Versus Imiquimod 5% in Treatment of Ano-genital Warts: Combined Results From Triple Blind Controlled Study

• Status: Recruiting
• Trial end date: 2020-05-20
• Target enrollment: 0
• Participant gender: All

Summary

In order to determine the Efficacy of Betaglucin 0.2% in gel vs Imiquimod 5% cream in the treatment of 102 individuals older than 18 years with anogenital warts trials in two arms 51 with Betaglucin 0.2% and 51 with Imiquimod 5%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri
• Collaborators: Bioanalisis; CALOX Laboratories
• Treatments: Imiquimod

Criteria

Inclusion Criteria:

• Men and women aged 18 to 50 years with anogenital wart visible on physical examination and positive for HPV 6 and 11 by polymerase chain reaction (PCR) test with detection by agarose gel electrophoresis.

Exclusion Criteria:

• Pregnant women.

• Vaccinated against human papillomavirus (Gardasil, Gardasil 9 or Cervarix).

• Patients Immunosuppressed by drugs (Chemotherapy, Corticoids, use of antibiotics for more than 7 days and/or antituberculous treatment.)

• Molluscum contagiosum.

• Skin Appendages.

• Urethral prolapse.

• Botryoid sarcoma.

• Herpes type II.

• History of anogenital surgery in the last 4 weeks.

• Intake of natural products or immunomodulators.

• Patients who have received 5% imiquimod cream.