Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs)

Exclusion Criteria

• •1. Patients with peri-anal warts.
• •2. Male patients with warts on scrotum or perineum.
• •3. Patients with other genital infections.
• •4. Patients with internal genital warts (such as urethral, intra-vaginal, cervical, rectal, or intra-anal genital warts).
• •5. Patients with active systemic infections.
• •6. Patients with other genital diseases that may confound evaluation and treatment for genital warts.
• •7. Patients with immuno-compromised medical condition.
• •8. Patients have received investigational drug prior to 30 days of randomization visit.
• •9. Patients with cancer or cancer history within 5 years of the randomization visit.
• •10. Patients have on-going human papilloma virus (HPV) infection other than genital area.
• •11. Patients with human immunodeficiency virus (HIV), venereal disease research laboratory (VDRL), or treponema pallidum particle agglutination assay (TPHA) positive result.
• •12. Female patients have high-grade pathology in Papanicolaou smear tests based on Bethesda system.
• •13. Female patients are pregnant or lactating.
• •14. Patients have history of allergy or sensitivity to Solanum undatum plant extract, SM, or SR-T100 gel excipients including carbomer, propylene glycol, and triethanolamine.
• •15. Patients with prohibited pre-medication or procedures shown below:
• •1. Physical modalities, such as laser ablation, electrocautery or cryotherapy, for genital warts treatment on treated area within 4 weeks prior to randomization visit.
• •2. Topical administered medication for genital warts treatment, such as polyphenon E, podophyllotoxin, imiquimod, or 5-fluorouracil (5-FU), within 12 weeks prior to randomization.
• •3. Medications of cytotoxic, immunomodulator (inhaled and topical steroid not on ano-genital areas are not prohibited), systematic antiviral agent in 4 weeks prior to randomization visit.