A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical … (NCT02724254) | Clinical Trial Compass
CompletedPhase 2
A 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
Argentina218 participantsStarted 2016-01
Plain-language summary
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
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female patient aged between 18 and 55 years.
✓. External condylomas, 2-30 lesions (no more than 2 lesions side by side); flat or papular, but not pediculated.
✓. Lesions must not be internal. Lesions that originate internally, but are visible externally will be considered internal and are not allowed in the study.
✓. Total wart area (diameter x diameter) should not be less than 10mm2 and not more than 800 mm2
✓. Individual wart area should not measure more than 50mm2, and the major perpendicular diameter should not measure more than 10mm (1cm).
✓. Lesions to be treated should have appeared between 1 to 6 months before screening, and patients should not have received any previous condyloma treatment during the last 2 months before enrollment.
✓. For female patients: either postmenopausal, taking adequate contraceptive method or surgically sterile.
Exclusion criteria
✕. Patients should not have received genital wart treatment for previous condylomas (other than the prior treatment for current condylomas referred at inclusion criteria) in the last 12 months before enrollment
✕. Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, transplanted or immunosuppressed patients or other clinical condition that, in the Investigator's judgment, prevents the patients from participating to the study.
What they're measuring
1
Percentage of patients with at least one local skin reaction (LSR)