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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02535104
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Tamir Biotechnology, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Condylomata Acuminata Papillomavirus Infections Sexually Transmitted Diseases Drug: Ranpirnase Drug: Vehicle Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : February 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group
1 mg/ml solution of ranpirnase applied twice daily
 Drug: Ranpirnase
Topical application by subject
Other Name: Onconase
Placebo Comparator: Control
Vehicle - innert gel
 Drug: Vehicle
Vehicle control
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of lesions [ Time Frame: Up to 60 days ]
    Number of lesions present at Week 8


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02535104


Locations
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Bolivia
IDH
Cochabamba, Bolivia
Sponsors and Collaborators
Tamir Biotechnology, Inc.
Investigators
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Study Chair: Edgar Valdez, MD Director - Research site
More Information
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Responsible Party: Tamir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT02535104    
Other Study ID Numbers: TAMIR1501HPV
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Papillomavirus Infections
Condylomata Acuminata
Communicable Diseases
Infections
Genital Diseases
Urogenital Diseases
Disease Attributes
Pathologic Processes
Sexually Transmitted Diseases, Viral
DNA Virus Infections
 Virus Diseases
Tumor Virus Infections
Warts
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Ranpirnase
Antineoplastic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action