Sinecatechins 10% Ointment for External Genital Warts
Sinecatechins 10% Ointment for External Genital Warts
No serious adverse events (AEs) were reported in the Phase II/III study. Only two participants in the sinecatechins 10% group had AEs considered possibly or probably related to the study drug and these included hyperkeratosis and skin discoloration. A number of local skin reactions were reported, but no significant differences in severe local reactions between active treatment groups and placebo were found. AE rates were also similar between treatment groups and vehicle in the Phase III trials. One patient in the sinecatechins 10% group developed severe pustular vulvovaginitis, which was considered related to study drug. Three patients in the other Phase III trial developed moderate lymphadenitis, moderate rash, and moderate phimosis, all were considered possibly related to the study medication. The overall incidence of any local reaction during treatment was higher in active treatment groups than vehicle (85.9% and 82.9% vs. 60.4%). Incidence of most common application-site reactions are presented in Table 2. In all studies, application-site reactions declined over the study period regardless of initial intensity. It has been suggested that local reactions such as erythema are associated with the release of pro-inflammatory cytokines; thus, patients should be advised that these signs may be indicative of clinical response and are correlated with higher clearance rates. Sinecatechins 10% ointment is contraindicated in individuals with a history of hypersensitivity to any of its components and treatment should be discontinued if hypersensitivity occurs.
Safety and Adverse Events
No serious adverse events (AEs) were reported in the Phase II/III study. Only two participants in the sinecatechins 10% group had AEs considered possibly or probably related to the study drug and these included hyperkeratosis and skin discoloration. A number of local skin reactions were reported, but no significant differences in severe local reactions between active treatment groups and placebo were found. AE rates were also similar between treatment groups and vehicle in the Phase III trials. One patient in the sinecatechins 10% group developed severe pustular vulvovaginitis, which was considered related to study drug. Three patients in the other Phase III trial developed moderate lymphadenitis, moderate rash, and moderate phimosis, all were considered possibly related to the study medication. The overall incidence of any local reaction during treatment was higher in active treatment groups than vehicle (85.9% and 82.9% vs. 60.4%). Incidence of most common application-site reactions are presented in Table 2. In all studies, application-site reactions declined over the study period regardless of initial intensity. It has been suggested that local reactions such as erythema are associated with the release of pro-inflammatory cytokines; thus, patients should be advised that these signs may be indicative of clinical response and are correlated with higher clearance rates. Sinecatechins 10% ointment is contraindicated in individuals with a history of hypersensitivity to any of its components and treatment should be discontinued if hypersensitivity occurs.
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