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Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT02535104•Tamir Biotechnology, Inc.

View on ClinicalTrials.gov

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.

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

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (1)

IDH

Cochabamba, Bolivia

Key Dates

Start Date

February 1, 2016

Primary Completion Date

September 1, 2016

Completion Date

September 1, 2016

Last Updated

June 6, 2018

Enrollment

ACTUAL participants

Conditions

Condylomata AcuminataPapillomavirus InfectionsSexually Transmitted Diseases

Interventions

Ranpirnase

DRUG

Vehicle

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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