Topical NVN1000 for the Treatment of External Genital and Perianal Warts

• Status: Completed
• Trial end date: 2016-10-17
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novan, Inc.
• Collaborator: PPD

Criteria

Inclusion Criteria:

• At least 2 but not more than 20 genital/perianal warts with a maximum total wart surface area no more than 1% body surface area

• If a woman of child-bearing potential, have a negative pregnancy test and use effective contraception

• If currently receiving wart treatment, be willing to stop all treatment for 28 days prior to randomization and during the study

Exclusion Criteria:

• Immunocompromised patients including those with HIV, receiving radiation, or drugs that suppress the immune system

• Pregnant, planning to become pregnant, or nursing

• History of cancer (including cervical cancer) within 5 years, with exception of non-melanoma skin cancer in non-genital skin

• Recent history of other genital skin infections

• Active HSV and frequent HSV recurrences unless receiving suppression therapy

• Have hemoglobin < 10 G/dl or methemoglobin > 3%

• Known allergy to any component of the gel including excipients

• Previously participated in any study with NVN1000 or SB204