Clinical trial · Interventional
Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)
Phase II Clinical Study, Double Blinded, Multicentric, Controlled Against Placebo, in Parallel Groups, to Evaluate the Efficacy and Safety of a Topical Product Containing Ranpirnase in Genital Warts - HPV
NCT02535104CI-TRIAL-00033192completedPhase 1 / Phase 2ClinicalTrials.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)
Ranpirnase in topical formulation is an antiviral drug being evaluated for the topical treatment of anogenital warts. The aims of this study is to evaluate the efficacy and safety of a topical formulation of ranpirnase in subjects with genital warts.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Condylomata Acuminata | — | UNRESOLVED | — |
| Papillomavirus Infections | — | UNRESOLVED | — |
| Sexually Transmitted Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ranpirnase | Drug | — | UNRESOLVED |
| Vehicle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- 1 mg/ml solution of ranpirnase applied twice daily
- interventionNames
- Drug: Ranpirnase
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Vehicle - innert gel
- interventionNames
- Drug: Vehicle
Primary outcomes (1)
- measure
- Size of lesions
- timeFrame
- Up to 60 days
- description
- The primary endpoint is the percentage change from baseline in total area of lesions at Week 8
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 lesions * Accept to follow study instructions / signature of IC * Abstain from sexual intercourse for 6 hours after applying the study product during the time of the study. Exclusion Criteria: * Any topical and/or destructive treatments for external genital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrollment (i.e., the randomization visit) * Non pregnant. For women in reproductive age it would be required pregnancy test, and the use of double barrier contraceptives. * Any of the following conditions: * Known allergy to the study product * Internal (rectal, urethral) warts that required or were undergoing treatment; * A dermatological disease (e.g., psoriasis) or skin condition in the area, which may interfere with the evaluation. * Imiquimod 5% cream (Aldara®) * Any marketed or investigational HPV vaccines * Sinecatechins (Veregen) * Interferon or interferon inducers * Cytotoxic drugs * Immunomodulators or immunosuppressives * Oral or parenteral corticosteroids (inhaled/intranasal steroids are permitted) * Oral antiviral drugs (with the exception of HAART, oral acyclovir and acyclovir related drugs) for suppressive or acute therapy herpes; or oseltamivir for prophylaxis or for influenza) * Topical antiviral drugs (including topical acyclovir and acyclovir related drugs) in the areas under treatment * Podophyllotoxin/Podofilox in the treatment areas * Any topical prescription medications in the treatment areas * Dermatologic procedures or surgery in the treatment areas
References
Publications (0)
Data not yet available
No reference posted for this study.