This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety, tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074 5% Gel for up to 16 weeks in condyloma patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
218
Anaconda Invesigational Site
Buenos Aires, Argentina
Anaconda Investigational Site
Buenos Aires, Argentina
Anaconda Investigational Site
Córdoba, Argentina
Percentage of patients with at least one local skin reaction (LSR)
Time frame: Day 0 to Week 16
Number of patients experiencing adverse events
Time frame: Day 0 to Week 16
Mean plasma concentrations of AP611074-04
Time frame: Day 0 to 2 weeks post end of treatment
Proportion of subjects with a complete clearance rate (100%) for baseline genital wart lesions
Time frame: Day 0 to week 16
Reduction in the total condyloma area for lesions
Time frame: Day 0 to week 16
Proportion of subjects with a complete clearance rate (100%) for all genital wart lesions
Time frame: Day 0 to week 16
Time to complete clearance
Time frame: Day 0 to week 16
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Anaconda Investigational Site
Mendoza, Argentina
Anaconda Investigational Site
Sante Fe, Argentina
Anaconda Investigational Site
Concepción, Chile
Anaconda Investigational Site
Santiago, Chile
Anaconda Investigational Site
Cumbayá, Ecuador
Anaconda Investigational Site
Guayaquil, Ecuador
Anaconda Investigational Site
Quito, Ecuador
...and 2 more locations