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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AP611074 5% gel | Experimental | 100 mg twice daily doses of AP611074 5% gel |
|
| Placebo | Placebo Comparator | AP611074 matching placebo gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP611074 5% gel | Drug |
| ||
| AP611074 matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with at least one local skin reaction (LSR) | Day 0 to Week 16 | |
| Number of patients experiencing adverse events | Day 0 to Week 16 | |
| Mean plasma concentrations of AP611074-04 | Day 0 to 2 weeks post end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a complete clearance rate (100%) for baseline genital wart lesions | Day 0 to week 16 | |
| Reduction in the total condyloma area for lesions | Day 0 to week 16 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Novotney-Barry | Aviragen Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaconda Invesigational Site | Buenos Aires | Argentina | ||||
| Anaconda Investigational Site |
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|
| Proportion of subjects with a complete clearance rate (100%) for all genital wart lesions |
| Day 0 to week 16 |
| Time to complete clearance | Day 0 to week 16 |
| Buenos Aires |
| Argentina |
| Anaconda Investigational Site | Córdoba | Argentina |
| 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 |
| Anaconda Investigational Site | Belgrade | Serbia |
| Anaconda Investigational Site | Novi Sad | Serbia |
| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D012749 | Sexually Transmitted Diseases |
| D030361 | Papillomavirus Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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