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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02462187
Other study ID # NI-WA201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 12, 2015
Est. completion date October 17, 2016

Study information

Verified date April 2023
Source Novan, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date October 17, 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
NVN1000 8% Gel
once and twice daily
NVN1000 16%
once daily
Vehicle
placebo comparator
NVN1000 24%
once daily

Locations

Country Name City State
United States PPD 134 Atlanta Georgia
United States PPD 139 Atlanta Georgia
United States PPD 128 Corpus Christi Texas
United States PPD 137 Fountain Valley California
United States PPD 129 Houston Texas
United States PPD 130 Indianapolis Indiana
United States PPD 140 Lomita California
United States PPD 126 Metairie Louisiana
United States PPD 135 Philadelphia Pennsylvania
United States PPD 132 Portland Oregon
United States PPD 138 Roswell Georgia
United States PPD 127 San Antonio Texas
United States PPD 133 San Diego California
United States PPD 136 Seattle Washington
United States PPD 131 Webster Texas

Sponsors (2)

Lead Sponsor Collaborator
Novan, Inc. PPD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Baseline, Week 2, Week 4, Week 8, Week 12
Secondary 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. Baseline, Week 2 and Week 12
Secondary 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 12 weeks
Secondary 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 12 weeks
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