SINECATECHINS OINT,TOP
Clinical Criteria Summary
Exclusion Criteria
- Immunocompromised patient
- Treatment of urethral, intra-vaginal, cervical, rectal or intra-anal human papilloma viral disease
- Application to open wounds
Inclusion Criteria
- Patient is under the care of a dermatologist, gynecologist, urologist, or Women’s Health provider and meets one of the following conditions:
- Extensive or severe external genital or perianal warts (Both must be selected to be eligible):
- Large number (≥ 10) of individual warts or warts involving large areas of skin in areas otherwise difficult to treat with typical destructive modalities such as cryotherapy, podophyllin or trichloroacetic acid
- Documented inadequate response or intolerance to other patient-administered agents (podofilox for at least 4 one-week cycles and imiquimod for at least 4 one-week cycles)
- Isolated external genital warts (<10) on penile shaft, glans or vulvar areas or isolated perianal warts (Both must be selected to be eligible):
- Documented inadequate response or intolerance to at least two of these treatment modalities: topical 0.5% podofilox (at least 4 one-week cycles), podophyllin 25% (at least 4 weekly applications), trichloroacetic acid (80% or higher strength for at least 4 weekly applications), and cryotherapy (at least 4 cycles)
- Documented inadequate response or intolerance to imiquimod (at least 4 one-week cycles)
Dosage and Administration
- Topical administered three times per day until complete clearance of all warts (maximum of 16 weeks of therapy)
- Each wart should receive approximately 0.5cm strand of sinecatechins to ensure complete coverage
Recommended Monitoring
- Tolerability of local adverse effects
- Patient adherence to dosage regimen
Issues for Consideration / FDA Approved Indication
- Sinecatechins 15% ointment is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminate) due to human papillomavirus infection (HPV) in immunocompetent patients 18 years and older.