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

June 4, 2018 updated by: Tamir Biotechnology, Inc.

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
1 mg/ml solution of ranpirnase applied twice daily
Topical application by subject
Other Names:
  • Onconase
Placebo Comparator: Control
Vehicle - innert gel
Vehicle control
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 60 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Edgar Valdez, MD, Director - Research site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 22, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

March 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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