At a glance
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An Investigator-Initiated Study to Assess the Safety and Efficacy of Sinecatechins 15% Ointment When Used in Conjunction With Cryotherapy in the Treatment of External Genital Warts
In Brief
A clinical study evaluating Sinecatechins 15% Ointment and Cryotherapy alone for External Genital Warts. Completed, enrolled 42 participants across 1 site.
Detailed Summary
External Genital Warts (EGW) are the most common sexually transmitted disease associated with more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective method of EGW treatment. However, multiple sessions may be required with reported clearance rates ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration approved for three times daily application in immunocompetent subjects 18 years and older for the treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy, treating both clinical and sub-clinical lesions. For this study, the investigators used sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also anticipated that the sequential therapy with be safe.
Study Details
Timeline
Interventions
Following cryotherapy, half of the subjects will be randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy (Week 1).
Cryotherapy will be standardized in all subjects and for all treated lesions.