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

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

Study Overview

• Status: Completed
• Conditions: Genital Warts; Perianal Warts
• Intervention / Treatment: Drug: NVN1000 8% Gel; Drug: NVN1000 16%; Drug: Vehicle; Drug: NVN1000 24%

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92708
      • PPD 137
    • Lomita, California, United States, 90717
      • PPD 140
    • San Diego, California, United States, 92123
      • PPD 133
  • Georgia
    • Atlanta, Georgia, United States, 30005
      • PPD 134
    • Atlanta, Georgia, United States, 30338
      • PPD 139
    • Roswell, Georgia, United States, 30075
      • PPD 138
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • PPD 130
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • PPD 126
  • Oregon
    • Portland, Oregon, United States, 97210
      • PPD 132
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • PPD 135
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • PPD 128
    • Houston, Texas, United States, 77023
      • PPD 129
    • San Antonio, Texas, United States, 78229
      • PPD 127
    • Webster, Texas, United States, 75598
      • PPD 131
  • Washington
    • Seattle, Washington, United States, 98105
      • PPD 136

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVN1000 8% Gel twice daily	Drug: NVN1000 8% Gel; once and twice daily; Other Names: SB206
Experimental: NVN1000 8% Gel once daily	Drug: NVN1000 8% Gel; once and twice daily; Other Names: SB206
Experimental: NVN1000 16% Once daily; NVN1000 16% Gel once daily	Drug: NVN1000 16%; once daily; Other Names: SB206
Placebo Comparator: Vehicle Gel; Vehicle Gel at frequency to match active	Drug: Vehicle; placebo comparator; Other Names: Placebo
Experimental: NVN1000 24% once daily	Drug: NVN1000 24%; once daily; Other Names: SB206

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	12 weeks

Collaborators and Investigators

• Sponsor: Novan, Inc.
• Collaborators: PPD

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 17, 2016

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: perianal warts; genital warts
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Condylomata Acuminata
• Other Study ID Numbers: NI-WA201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO