Clinical trial NCT02724254: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Condyloma
Keywords: 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
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2016-03-31
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Male or female patient aged between 18 and 55 years.
2. External condylomas, 2-30 lesions (no more than 2 lesions side by side); flat or papular, but not pediculated.
3. Lesions must not be internal. Lesions that originate internally, but are visible externally will be considered internal and are not allowed in the study.
4. Total wart area (diameter x diameter) should not be less than 10mm2 and not more than 800 mm2
5. Individual wart area should not measure more than 50mm2, and the major perpendicular diameter should not measure more than 10mm (1cm).
6. 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.
7. For female patients: either postmenopausal, taking adequate contraceptive method or surgically sterile.

Exclusion Criteria:

1. 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
2. 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.
3. Patients with any clinically significant abnormality following review of screening laboratory tests, vital signs, full physical examination and ECG.
4. Patients with history or presence of drug or alcohol abuse.
5. Patients with positive HBs or HBc antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.
6. Patients using any dermatological drug therapy in the treatment area during the last month prior the first application of the study drug.

Primary outcomes:
measure: Percentage of patients with at least one local skin reaction (LSR)
timeFrame: Day 0 to Week 16
measure: Number of patients experiencing adverse events
timeFrame: Day 0 to Week 16
measure: Mean plasma concentrations of AP611074-04
timeFrame: Day 0 to 2 weeks post end of treatment
Secondary outcomes:
measure: Proportion of subjects with a complete clearance rate (100%) for baseline genital wart lesions
timeFrame: Day 0 to week 16
measure: Reduction in the total condyloma area for lesions
timeFrame: Day 0 to week 16
measure: Proportion of subjects with a complete clearance rate (100%) for all genital wart lesions
timeFrame: Day 0 to week 16
measure: Time to complete clearance
timeFrame: Day 0 to week 16
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Anaconda Invesigational Site
city: Buenos Aires
country: Argentina
facility: Anaconda Investigational Site
city: Cordoba
country: Argentina
facility: Anaconda Investigational Site
city: Córdoba
country: Argentina
facility: Anaconda Investigational Site
city: Mendoza
country: Argentina
facility: Anaconda Investigational Site
city: Sante Fe
country: Argentina
facility: Anaconda Investigational Site
city: Concepción
country: Chile
facility: Anaconda Investigational Site
city: Santiago
country: Chile
facility: Anaconda Investigational Site
city: Cumbaya
country: Ecuador
facility: Anaconda Investigational Site
city: Guayaquil
country: Ecuador
facility: Anaconda Investigational Site
city: Quito
country: Ecuador
facility: Anaconda Investigational Site
city: Belgrade
country: Serbia
facility: Anaconda Investigational Site
city: Novi Sad
country: Serbia
facility: Anaconda Investigational Site
Study officials:
affiliation: Aviragen Therapeutics, Inc.
name: Anna Novotney-Barry
role: STUDY_DIRECTOR
References: