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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2016

Detailed Description

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.

Interventions

  • Drug: Ranpirnase
    • Topical application by subject
  • Drug: Vehicle
    • Vehicle control

Arms, Groups and Cohorts

  • Experimental: Treatment group
    • 1 mg/ml solution of ranpirnase applied twice daily
  • Placebo Comparator: Control
    • Vehicle – innert gel

Clinical Trial Outcome Measures

Primary Measures

  • Size of lesions
    • Time Frame: Up to 60 days
    • The primary endpoint is the percentage change from baseline in total area of lesions at Week 8

Secondary Measures

  • Number of lesions
    • Time Frame: Up to 60 days
    • Number of lesions present at Week 8

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 60 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Tamir Biotechnology, Inc.
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Edgar Valdez, MD, Study Chair, Director – Research site

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.