Topical NVN1000 for the Treatment of External Genital and Perianal Warts

April 4, 2023 updated by: Novan, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12
Time Frame: 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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.
Baseline, Week 2, Week 4, Week 8, Week 12
Safety as Determined by Changes in Laboratory Assessments
Time Frame: 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.
Baseline, Week 2 and Week 12
Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12
Time Frame: 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
12 weeks
Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12
Time Frame: 12 weeks
Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novan, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PPD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NI-WA201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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