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Topical NVN1000 for the Treatment of External Genital and Perianal Warts

Primary Purpose

Genital Warts, Perianal Warts

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NVN1000 8% Gel
NVN1000 16%
Vehicle
NVN1000 24%
Sponsored by
Novan, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Warts focused on measuring genital warts, perianal warts

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PPD 137
  • PPD 140
  • PPD 133
  • PPD 134
  • PPD 139
  • PPD 138
  • PPD 130
  • PPD 126
  • PPD 132
  • PPD 135
  • PPD 128
  • PPD 129
  • PPD 127
  • PPD 131
  • PPD 136

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

NVN1000 8% Gel twice daily

NVN1000 8% Gel once daily

NVN1000 16% Once daily

Vehicle Gel

NVN1000 24% once daily

Arm Description

NVN1000 8% Gel twice daily

NVN1000 8% Gel once daily

NVN1000 16% Gel once daily

Vehicle Gel at frequency to match active

NVN1000 24% once daily

Outcomes

Primary Outcome Measures

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.

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
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
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 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
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

Full Information

First Posted
May 28, 2015
Last Updated
April 4, 2023
Sponsor
Novan, Inc.
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT02462187
Brief Title
Topical NVN1000 for the Treatment of External Genital and Perianal Warts
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novan, Inc.
Collaborators
PPD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Warts, Perianal Warts
Keywords
genital warts, perianal warts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NVN1000 8% Gel twice daily
Arm Type
Experimental
Arm Description
NVN1000 8% Gel twice daily
Arm Title
NVN1000 8% Gel once daily
Arm Type
Experimental
Arm Description
NVN1000 8% Gel once daily
Arm Title
NVN1000 16% Once daily
Arm Type
Experimental
Arm Description
NVN1000 16% Gel once daily
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel at frequency to match active
Arm Title
NVN1000 24% once daily
Arm Type
Experimental
Arm Description
NVN1000 24% once daily
Intervention Type
Drug
Intervention Name(s)
NVN1000 8% Gel
Other Intervention Name(s)
SB206
Intervention Description
once and twice daily
Intervention Type
Drug
Intervention Name(s)
NVN1000 16%
Other Intervention Name(s)
SB206
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Placebo
Intervention Description
placebo comparator
Intervention Type
Drug
Intervention Name(s)
NVN1000 24%
Other Intervention Name(s)
SB206
Intervention Description
once daily
Primary Outcome Measure Information:
Title
Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12
Description
Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 12
Title
Safety as Determined by Changes in Laboratory Assessments
Description
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.
Time Frame
Baseline, Week 2 and Week 12
Title
Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12
Description
The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator
Time Frame
12 weeks
Title
Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12
Description
Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce Rico, MD
Organizational Affiliation
Novan, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
PPD 137
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
PPD 140
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
PPD 133
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
PPD 134
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
PPD 139
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
PPD 138
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
PPD 130
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
PPD 126
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
PPD 132
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
PPD 135
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
PPD 128
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
PPD 129
City
Houston
State/Province
Texas
ZIP/Postal Code
77023
Country
United States
Facility Name
PPD 127
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
PPD 131
City
Webster
State/Province
Texas
ZIP/Postal Code
75598
Country
United States
Facility Name
PPD 136
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Topical NVN1000 for the Treatment of External Genital and Perianal Warts

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