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

Vaxart

Status and phase: Completed; Phase 2

Conditions: Condyloma

Treatments: Drug: AP611074 5% gel; Drug: AP611074 matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02724254

AP611074.CT4

Details and patient eligibility

About

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

Enrollment: 218 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups, including a placebo group

AP611074 5% gel

Experimental group

Description:

100 mg twice daily doses of AP611074 5% gel

Treatment:

Drug: AP611074 5% gel

Placebo

Placebo Comparator group

Description:

AP611074 matching placebo gel

Treatment:

Drug: AP611074 matching placebo