Phase 2
N=108
Topical NVN1000 for the Treatment of External Genital and Perianal Warts
Genital Warts · Perianal Warts
Bottom Line
View on ClinicalTrials.gov: NCT02462187 ↗Enrolled (actual)
108
Serious AEs
2.9%
Results posted
Apr 2023
Primary outcome: Primary: Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 — 2; 5; 2; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NVN1000 8% Gel (Drug); NVN1000 16% (Drug); Vehicle (Drug); NVN1000 24% (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novan, Inc.
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 |
2; 5; 2; 10; 1; 2 | — |
| SECONDARY Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch |
12; 23; 14; 27; 20; 4 | — |
| SECONDARY Safety as Determined by Changes in Laboratory Assessments |
1.33; 1.25; 1.38; 1.29; 1.31; 1.53 | — |
| SECONDARY Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12 |
2; 5; 2; 9; 1; 2 | — |
| SECONDARY Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12 |
8; 19; 10; 17; 11; 2 | — |
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
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 3%
- Known allergy to any component of the gel including excipients
- Previously participated in any study with NVN1000 or SB204
Data sourced from ClinicalTrials.gov (NCT02462187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.