Overview

This trial is active, not recruiting.

Conditions genital warts, perianal warts
Treatments nvn1000, vehicle gel
Phase phase 2
Sponsor Novan, Inc.
Collaborator PPD
Start date May 2015
End date December 2016
Trial size 108 participants
Trial identifier NCT02462187, NI-WA201

Summary

This is a 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
NVN1000 8% Gel twice daily
nvn1000 SB206
Applied topically, co-administered with hydrogel
(Experimental)
NVN1000 8% Gel once daily
nvn1000 SB206
Applied topically, co-administered with hydrogel
(Experimental)
NVN1000 16% Gel once daily
nvn1000 SB206
Applied topically, co-administered with hydrogel
(Placebo Comparator)
Vehicle Gel at frequency to match active
vehicle gel
Applied topically, co-administered with hydrogel
(Experimental)
NVN1000 24% once daily
nvn1000 SB206
Applied topically, co-administered with hydrogel

Primary Outcomes

Measure
Efficacy: Clearance of baseline external genital and perianal warts
time frame: 12 weeks

Secondary Outcomes

Measure
Tolerability of Topical NVN1000 Gel as determined by Scores on a 4 point grading scale for erythema, edema, erosions/ulcers, and itch
time frame: 12 weeks
Safety as determined by reported adverse events
time frame: 12 weeks
Safety as determined by changes in laboratory assessments
time frame: 12 weeks
Proportion of subjects with complete clearance of all warts
time frame: 12 weeks
Proportion of subjects with complete or partial clearance of baseline warts
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novan, Inc..