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Completed

NCT Number: NCT02535104

Safety and Efficacy Study of Topical Ranpirnase to Treat 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.

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Key information

Conditions

Condylomata Acuminata Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

IDH

Cochabamba, Bolivia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranpirnase

Drug

Topical application by subject

Other names: Onconase

Vehicle

Drug

Vehicle control

Other names: Placebo

Primary outcomes

  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 outcomes

  1. Number of lesions

    Time frame: Up to 60 days

    Number of lesions present at Week 8

Sponsors and collaborators

Lead sponsor

Tamir Biotechnology, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2015
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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