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
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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial that has already completed, has the safety and tolerability data been published, and what did it show about the local skin reactions that were being tracked as a primary outcome?
2The study applied AP611074 5% gel twice daily for up to 16 weeks — how does that kind of long treatment commitment compare to other condyloma treatments available to me right now, and would standard options be worth trying first?
3One of the main things this trial measured was how much of the gel gets absorbed into the bloodstream — do you know if the plasma concentration levels found in the study raised any concerns about systemic exposure that I should be aware of?
4Given that local skin reactions were specifically tracked as a primary safety outcome, what kinds of skin side effects were observed, and how would those compare to what I might experience with currently approved topical treatments for condyloma?
5Since this trial is completed but I cannot enroll, is there any follow-on study or related treatment using AP611074 that I might be eligible for, or does the data from this trial point toward a different treatment path for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients with at least one local skin reaction (LSR)
. 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.
. Patients with any clinically significant abnormality following review of screening laboratory tests, vital signs, full physical examination and ECG.
. Patients with history or presence of drug or alcohol abuse.
. Patients with positive HBs or HBc antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.
. Patients using any dermatological drug therapy in the treatment area during the last month prior the first application of the study drug.