NCT02462187

Topical NVN1000 for the Treatment of External Genital and Perianal Warts

A Phase 2, Multi-center, Double-blind, Randomized, Vehicle-controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects With External Genital Warts and Perianal Warts

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Novan, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts

Detailed description

This is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose study to assess safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects with external genital and perianal warts. Eligible subjects will be treated with a topical gel (active or vehicle) for up to 12 weeks.

Conditions

• Genital Warts
• Perianal Warts

Interventions

Type	Name	Description
DRUG	NVN1000 8% Gel	once and twice daily
DRUG	NVN1000 16%	once daily
DRUG	Vehicle	placebo comparator
DRUG	NVN1000 24%	once daily

Timeline

• Start date: 2015-06-12
• Primary completion: 2016-10-01
• Completion: 2016-10-17
• First posted: 2015-06-03
• Last updated: 2023-04-06
• Results posted: 2023-04-05

Locations

15 sites across 1 country: United States