Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)

Study Overview
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Brief Summary
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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.

Detailed Description
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The study consists of the evaluation of 4 weeks exposure to the study product; designed as randomized, double blinded, against vehicle to study the effects of 1 mg/ml concentration of ranpirnase on anogenital warts. The dermal reaction are scored on a scale that describes the amount of erythema, edema, and other features indicative of irritation. The clinical response are be scored on the basis of the percentage of the reduction of the lesions in size and number.

Official Title
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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

Conditions
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Condylomata Acuminata, Papillomavirus Infections, Sexually Transmitted Diseases

Intervention / Treatment
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* Drug: Ranpirnase
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>1 mg/ml solution of ranpirnase applied twice daily | Drug: Ranpirnase<br>* Topical application by subject<br>* Other names: Onconase;|
| Placebo Comparator: Control<br>Vehicle - innert gel | Drug: Vehicle<br>* Vehicle control<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of lesions | The primary endpoint is the percentage change from baseline in total area of lesions at Week 8 | Up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of lesions | Number of lesions present at Week 8 | Up to 60 days |