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

Condyloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724254
• Other study ID #: AP611074.CT4
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: Vaxart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Condyloma
• Condylomata Acuminata

Intervention

Drug:
• AP611074 5% gel

• AP611074 matching placebo

Locations

Country	Name	City	State
Argentina	Anaconda Invesigational Site	Buenos Aires
Argentina	Anaconda Investigational Site	Buenos Aires
Argentina	Anaconda Investigational Site	Cordoba
Argentina	Anaconda Investigational Site	Córdoba
Argentina	Anaconda Investigational Site	Mendoza
Argentina	Anaconda Investigational Site	Sante Fe
Chile	Anaconda Investigational Site	Concepción
Chile	Anaconda Investigational Site	Santiago
Ecuador	Anaconda Investigational Site	Cumbaya
Ecuador	Anaconda Investigational Site	Guayaquil
Ecuador	Anaconda Investigational Site	Quito
Serbia	Anaconda Investigational Site	Belgrade
Serbia	Anaconda Investigational Site	Novi Sad

Sponsors (1)

Lead Sponsor	Collaborator
Vaxart

Countries where clinical trial is conducted

Argentina,  Chile,  Ecuador,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with at least one local skin reaction (LSR)		Day 0 to Week 16
Primary	Number of patients experiencing adverse events		Day 0 to Week 16
Primary	Mean plasma concentrations of AP611074-04		Day 0 to 2 weeks post end of treatment
Secondary	Proportion of subjects with a complete clearance rate (100%) for baseline genital wart lesions		Day 0 to week 16
Secondary	Reduction in the total condyloma area for lesions		Day 0 to week 16
Secondary	Proportion of subjects with a complete clearance rate (100%) for all genital wart lesions		Day 0 to week 16
Secondary	Time to complete clearance		Day 0 to week 16