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

July 18, 2018 updated by: Vaxart

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Anaconda Invesigational Site
      • Buenos Aires, Argentina
        • Anaconda Investigational Site
      • Cordoba, Argentina
        • Anaconda Investigational Site
      • Córdoba, Argentina
        • Anaconda Investigational Site
      • Mendoza, Argentina
        • Anaconda Investigational Site
      • Sante Fe, Argentina
        • Anaconda Investigational Site
  • Chile
      • Concepción, Chile
        • Anaconda Investigational Site
      • Santiago, Chile
        • Anaconda Investigational Site
  • Ecuador
      • Cumbaya, Ecuador
        • Anaconda Investigational Site
      • Guayaquil, Ecuador
        • Anaconda Investigational Site
      • Quito, Ecuador
        • Anaconda Investigational Site
  • Serbia
      • Belgrade, Serbia
        • Anaconda Investigational Site
      • Novi Sad, Serbia
        • Anaconda Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AP611074 5% gel
100 mg twice daily doses of AP611074 5% gel
Drug: AP611074 5% gel
PLACEBO_COMPARATOR: Placebo
AP611074 matching placebo gel
Drug: AP611074 matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with at least one local skin reaction (LSR)
Time Frame: Day 0 to Week 16
Day 0 to Week 16
Number of patients experiencing adverse events
Time Frame: Day 0 to Week 16
Day 0 to Week 16
Mean plasma concentrations of AP611074-04
Time Frame: Day 0 to 2 weeks post end of treatment
Day 0 to 2 weeks post end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with a complete clearance rate (100%) for baseline genital wart lesions
Time Frame: Day 0 to week 16
Day 0 to week 16
Reduction in the total condyloma area for lesions
Time Frame: Day 0 to week 16
Day 0 to week 16
Proportion of subjects with a complete clearance rate (100%) for all genital wart lesions
Time Frame: Day 0 to week 16
Day 0 to week 16
Time to complete clearance
Time Frame: Day 0 to week 16
Day 0 to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vaxart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (ESTIMATE)

March 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP611074.CT4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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