Topical NVN1000 for the Treatment of External Genital and Perianal Warts
NCT ID: NCT02462187
Last Updated: 2023-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2015-06-12
2016-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NVN1000 8% Gel twice daily
NVN1000 8% Gel twice daily
NVN1000 8% Gel
once and twice daily
NVN1000 8% Gel once daily
NVN1000 8% Gel once daily
NVN1000 8% Gel
once and twice daily
NVN1000 16% Once daily
NVN1000 16% Gel once daily
NVN1000 16%
once daily
Vehicle Gel
Vehicle Gel at frequency to match active
Vehicle
placebo comparator
NVN1000 24% once daily
NVN1000 24% once daily
NVN1000 24%
once daily
Interventions
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NVN1000 8% Gel
once and twice daily
NVN1000 16%
once daily
Vehicle
placebo comparator
NVN1000 24%
once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
Novan, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joyce Rico, MD
Role: STUDY_DIRECTOR
Novan, Inc.
Locations
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PPD 137
Fountain Valley, California, United States
PPD 140
Lomita, California, United States
PPD 133
San Diego, California, United States
PPD 134
Atlanta, Georgia, United States
PPD 139
Atlanta, Georgia, United States
PPD 138
Roswell, Georgia, United States
PPD 130
Indianapolis, Indiana, United States
PPD 126
Metairie, Louisiana, United States
PPD 132
Portland, Oregon, United States
PPD 135
Philadelphia, Pennsylvania, United States
PPD 128
Corpus Christi, Texas, United States
PPD 129
Houston, Texas, United States
PPD 127
San Antonio, Texas, United States
PPD 131
Webster, Texas, United States
PPD 136
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NI-WA201
Identifier Type: -
Identifier Source: org_study_id
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