Topical NVN1000 for the Treatment of External Genital and Perianal Warts

NCT02462187 | Completed Phase 2 Results DMC

• 1 other identifier: NI-WA201
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 15

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

Conditions

Genital Warts; Perianal Warts

Keywords

genital warts; perianal warts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Safety as Determined by Changes in Laboratory Assessments

  Baseline, Week 2 and Week 12

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

  12 weeks

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

  12 weeks

Study Arms (5)

NVN1000 8% Gel twice daily

EXPERIMENTAL

NVN1000 8% Gel twice daily

Drug: NVN1000 8% Gel

NVN1000 8% Gel once daily

EXPERIMENTAL

NVN1000 8% Gel once daily

Drug: NVN1000 8% Gel

NVN1000 16% Once daily

EXPERIMENTAL

NVN1000 16% Gel once daily

Drug: NVN1000 16%

Vehicle Gel

PLACEBO COMPARATOR

Vehicle Gel at frequency to match active

Drug: Vehicle

NVN1000 24% once daily

EXPERIMENTAL

NVN1000 24% once daily

Drug: NVN1000 24%

Interventions

NVN1000 8% Gel DRUG

once and twice daily

Also known as: SB206

NVN1000 8% Gel once daily; NVN1000 8% Gel twice daily

NVN1000 16% DRUG

once daily

Also known as: SB206

NVN1000 16% Once daily

Vehicle DRUG

placebo comparator

Also known as: Placebo

Vehicle Gel

NVN1000 24% DRUG

once daily

Also known as: SB206

NVN1000 24% once daily

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novan, Inc.: lead
• PPD Development, LP: collaborator

Study Sites (15)

PPD 137

Fountain Valley, California, 92708, United States

Location

PPD 140

Lomita, California, 90717, United States

Location

PPD 133

San Diego, California, 92123, United States

Location

PPD 134

Atlanta, Georgia, 30005, United States

Location

PPD 139

Atlanta, Georgia, 30338, United States

Location

PPD 138

Roswell, Georgia, 30075, United States

Location

PPD 130

Indianapolis, Indiana, 46202, United States

Location

PPD 126

Metairie, Louisiana, 70006, United States

Location

PPD 132

Portland, Oregon, 97210, United States

Location

PPD 135

Philadelphia, Pennsylvania, 19107, United States

Location

PPD 128

Corpus Christi, Texas, 78414, United States

Location

PPD 129

Houston, Texas, 77023, United States

Location

PPD 127

San Antonio, Texas, 78229, United States

Location

PPD 131

Webster, Texas, 75598, United States

Location

PPD 136

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

berdazimer sodium; Gels

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Cathy White, Vice President, Drug Development Operations
• Organization: Novan, Inc.

clinical@novan.com

919-485-8080

Study Officials

• Joyce Rico, MD

  Novan, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 3, 2015
• Study Start: June 12, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 17, 2016
• Last Updated: April 6, 2023
• Results First Posted: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)