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

Study Overview
=================
Brief 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

Official Title
-----------------
A Double-blind Placebo Controlled, Randomized, Phase II 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

Conditions
-----------------
Condyloma

Intervention / Treatment
-----------------
* Drug: AP611074 5% gel
* Drug: AP611074 matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AP611074 5% gel<br>100 mg twice daily doses of AP611074 5% gel | Drug: AP611074 5% gel<br> <br> |
| Placebo Comparator: Placebo<br>AP611074 matching placebo gel | Drug: AP611074 matching placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genital warts, HPV types, Sexually Transmitted Disease, Papillomavirus Infections, Viral Disease, Anogenital warts, AGW, HPV6, HPV11, Human papillomavirus infection, HPV, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen