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

NCT02724254 Phase 2 COMPLETED

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

Details

Lead sponsor	Vaxart
Phase	Phase 2
Status	COMPLETED
Enrolment	218
Start date	2016-01
Completion	2018-07

Conditions

• Condyloma

Interventions

• AP611074 5% gel
• AP611074 matching placebo

Primary outcomes

• 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

Countries

Argentina, Chile, Ecuador, Serbia