Clinical trial · Interventional
Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Assessment of the Safety, Tolerability, and Activity of GS-9191 Ointment for the Treatment of External Genital and Perianal Warts Caused by Human Papilloma Virus Infection
NCT00499967CI-TRIAL-00002203completedPhase 1ClinicalTrials.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)
The purpose of this study is to assess the safety, tolerability and activity of GS-9191 ointment in the treatment of genital warts. GS-9191 ointment is intended for topical application directly to genital warts on the skin.
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GS-9191 | Drug | — | UNRESOLVED |
| GS-9191 ointment | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- GS-9191 0.01% ointment
- interventionNames
- Drug: GS-9191 ointment
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- GS-9191 0.03% ointment
- interventionNames
- Drug: GS-9191 ointment
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- GS-9191 0.1% ointment
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Have 2 or more genital warts of prespecified sizes on external surfaces of the body. * If HIV positive, have HIV RNA \< 400 copies/mL, CD4 count of ≥ 400 cells/mm3, and be taking a triple combination antiviral medication regimen Exclusion Criteria: * Prior genital wart treatment within 8 weeks * Pregnancy or breast-feeding * Presence of broken or non-intact skin near the wart site or other skin disease at the wart site (e.g., herpes genitalis) * Treatment with systemic steroids, systemic immunomodulators, immunosuppressants, or chemotherapeutic agents within 3 months * Current or prior diagnosis of Bowenoid papulosis, cancer, or pre-cancerous tissue in the genital area
References
Publications (0)
Data not yet available
No reference posted for this study.