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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tamir Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT02535104
First received: August 22, 2015
Last updated: March 28, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Condylomata Acuminata
Papillomavirus Infections
Sexually Transmitted Diseases
Drug: Ranpirnase
Drug: Vehicle
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tamir Biotechnology, Inc.:

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


Enrollment: 70
Study Start Date: February 2016
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02535104

Locations
Bolivia
IDH
Cochabamba, Bolivia
Sponsors and Collaborators
Tamir Biotechnology, Inc.
Investigators
Study Chair: Edgar Valdez, MD Director - Research site
  More Information

Responsible Party: Tamir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT02535104     History of Changes
Other Study ID Numbers: TAMIR1402HPV
Study First Received: August 22, 2015
Last Updated: March 28, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Papillomavirus Infections
Condylomata Acuminata
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
DNA Virus Infections
Tumor Virus Infections
Warts
Sexually Transmitted Diseases, Viral
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Ranpirnase
Antineoplastic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017