Topical NVN1000 for the Treatment of External Genital and Perianal Warts

Novan, Inc.108 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

108

Conditions

Genital Warts Perianal Warts

Interventions

NVN1000 8% GelDRUG

once and twice daily

NVN1000 16%DRUG

once daily

VehicleDRUG

placebo comparator

NVN1000 24%

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (15)

PPD 137

Fountain Valley, California, United States

PPD 140

Lomita, California, United States

PPD 133

San Diego, California, United States

Outcomes

Primary Outcomes

Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12

Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.

Time frame: 12 weeks

Secondary Outcomes

Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch

Comparison of scores for erythema, edema, erosions/ulcers, itch between active and vehicle treated subjects using a 4 point grading scale; on the tolerability scale, 0 = none and 3 = severe, indicating an increase in severity the higher the number assigned.

Time frame: Baseline, Week 2, Week 4, Week 8, Week 12

Safety as Determined by Changes in Laboratory Assessments

Safety population--Comparison of changes in methemoglobin levels between active and vehicle treated subjects. Methemoglobin levels were measured using a RAD-57 pulse co-oximeter. Values are expressed as a percentage of hemoglobin.

Time frame: Baseline, Week 2 and Week 12

Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12

The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator

Time frame: 12 weeks

Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12

Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator

Time frame: 12 weeks

Data from ClinicalTrials.gov

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