Topical NVN1000 for the Treatment of External Genital and Perianal Warts

Genital Warts Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462187
• Other study ID #: NI-WA201
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Condylomata Acuminata
• Genital Warts
• Perianal Warts
• Warts

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