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Topical NVN1000 for the Treatment of External Genital and Perianal Warts

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02462187
First Posted: June 3, 2015
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PPD
Information provided by (Responsible Party):
Novan, Inc.
  Purpose
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.

Condition Intervention Phase
Genital Warts Perianal Warts Drug: NVN1000 Other: Vehicle Gel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novan, Inc.:

Primary Outcome Measures:
  • Efficacy: Clearance of baseline external genital and perianal warts [ Time Frame: 12 weeks ]
    Clearance of baseline external genital and perianal warts as determined by physical examination by the investigator


Secondary Outcome Measures:
  • 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 ]
    Comparison of scores for erythema, edema, erosions/ulcers, itch between active and vehicle treated subjects using a 4 point grading scale

  • Safety as determined by reported adverse events [ Time Frame: 12 weeks ]
    Comparison of reported adverse events in active and vehicle treated subjects.

  • Safety as determined by changes in laboratory assessments [ Time Frame: 12 weeks ]
    Comparison of changes in laboratory assessments between active and vehicle treated subjects.

  • Proportion of subjects with complete clearance of all warts [ Time Frame: 12 weeks ]
    Clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator

  • Proportion of subjects with complete or partial clearance of baseline warts [ Time Frame: 12 weeks ]
    Reduction in the number of baseline warts as determined by physical examination by the investigator


Enrollment: 108
Study Start Date: May 2015
Estimated Study Completion Date: March 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVN1000 8% Gel twice daily
NVN1000 8% Gel twice daily
Drug: NVN1000
Applied topically, co-administered with hydrogel
Other Name: SB206
Experimental: NVN1000 8% Gel once daily
NVN1000 8% Gel once daily
Drug: NVN1000
Applied topically, co-administered with hydrogel
Other Name: SB206
Experimental: NVN1000 16% Once daily
NVN1000 16% Gel once daily
Drug: NVN1000
Applied topically, co-administered with hydrogel
Other Name: SB206
Placebo Comparator: Vehicle Gel
Vehicle Gel at frequency to match active
Other: Vehicle Gel
Applied topically, co-administered with hydrogel
Experimental: NVN1000 24% once daily
NVN1000 24% once daily
Drug: NVN1000
Applied topically, co-administered with hydrogel
Other Name: SB206

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462187


Locations
United States, California
PPD 137
Fountain Valley, California, United States, 92708
PPD 140
Lomita, California, United States, 90717
PPD 133
San Diego, California, United States, 92123
United States, Georgia
PPD 134
Atlanta, Georgia, United States, 30005
PPD 139
Atlanta, Georgia, United States, 30338
PPD 138
Rowell, Georgia, United States, 30075
United States, Indiana
PPD 130
Indianapolis, Indiana, United States, 46202
United States, Louisiana
PPD 126
Metairie, Louisiana, United States, 70006
United States, Oregon
PPD 132
Portland, Oregon, United States, 97210
United States, Pennsylvania
PPD 135
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
PPD 128
Corpus Christi, Texas, United States, 78414
PPD 129
Houston, Texas, United States, 77023
PPD 127
San Antonio, Texas, United States, 78229
PPD 131
Webster, Texas, United States, 75598
United States, Washington
PPD 136
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Novan, Inc.
PPD
Investigators
Study Director: Joyce Rico, MD Novan, Inc.
  More Information

Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT02462187     History of Changes
Other Study ID Numbers: NI-WA201
First Submitted: May 28, 2015
First Posted: June 3, 2015
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Novan, Inc.:
genital warts
perianal warts

Additional relevant MeSH terms:
Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases