Clinical trial · Interventional
Topical NVN1000 for the Treatment of External Genital and Perianal Warts
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
NCT02462187CI-TRIAL-00065366completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Warts | Condyloma Acuminatum | ALIAS | 0.90 |
| Perianal Warts | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NVN1000 16% | Drug | — | UNRESOLVED |
| NVN1000 24% | Drug | — | UNRESOLVED |
| NVN1000 8% Gel | Drug | — | UNRESOLVED |
| Vehicle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- NVN1000 8% Gel twice daily
- description
- NVN1000 8% Gel twice daily
- interventionNames
- Drug: NVN1000 8% Gel
- type
- EXPERIMENTAL
- label
- NVN1000 8% Gel once daily
- description
- NVN1000 8% Gel once daily
- interventionNames
- Drug: NVN1000 8% Gel
- type
- EXPERIMENTAL
- label
- NVN1000 16% Once daily
- description
- NVN1000 16% Gel once daily
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.