Topical NVN1000 for the Treatment of External Genital and Perianal Warts

Phase 2

Completed

• Conditions: Genital Warts; Perianal Warts
• Interventions: Drug: NVN1000 8% Gel; Drug: NVN1000 16%; Drug: Vehicle; Drug: NVN1000 24%

• Registration Number: NCT02462187
• Lead Sponsor: Novan, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-03
• Study Start: 2015-06-12
• Primary Completion: 2016-10
• Study Completion: 2016-10-17
• Disposition First Submitted: 2017-12-21
• Disposition First Submitted QC: 2017-12-21
• Disposition First Posted: 2017-12-27
• Results First Submitted: 2023-03-08
• Results First Submitted QC: 2023-03-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Results First Posted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NVN1000 8% Gel twice daily	NVN1000 8% Gel	NVN1000 8% Gel twice daily
NVN1000 8% Gel once daily	NVN1000 8% Gel	NVN1000 8% Gel once daily
NVN1000 16% Once daily	NVN1000 16%	NVN1000 16% Gel once daily
Vehicle Gel	Vehicle	Vehicle Gel at frequency to match active
NVN1000 24% once daily	NVN1000 24%	NVN1000 24% once daily

Primary Outcome Measures

Name	Time	Method
Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12	12 weeks	Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.

Secondary Outcome Measures

Name	Time	Method
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Baseline, Week 2, Week 4, Week 8, Week 12	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.
Safety as Determined by Changes in Laboratory Assessments	Baseline, Week 2 and Week 12	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.
Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12	12 weeks	Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator
Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12	12 weeks	The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator

Trial Locations

Locations (15)

PPD 137; 🇺🇸 Fountain Valley, California, United States

PPD 134; 🇺🇸 Atlanta, Georgia, United States

PPD 135; 🇺🇸 Philadelphia, Pennsylvania, United States

PPD 136; 🇺🇸 Seattle, Washington, United States

PPD 130; 🇺🇸 Indianapolis, Indiana, United States

PPD 129; 🇺🇸 Houston, Texas, United States

PPD 133; 🇺🇸 San Diego, California, United States

PPD 127; 🇺🇸 San Antonio, Texas, United States

PPD 140; 🇺🇸 Lomita, California, United States

PPD 138; 🇺🇸 Roswell, Georgia, United States

PPD 126; 🇺🇸 Metairie, Louisiana, United States

PPD 128; 🇺🇸 Corpus Christi, Texas, United States

PPD 131; 🇺🇸 Webster, Texas, United States

PPD 132; 🇺🇸 Portland, Oregon, United States

PPD 139; 🇺🇸 Atlanta, Georgia, United States