NCT02535104

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Tamir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Condylomata Acuminata
• Papillomavirus Infections
• Sexually Transmitted Diseases

Interventions

Type	Name	Description
DRUG	Ranpirnase	Topical application by subject
DRUG	Vehicle	Vehicle control

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-08-28
• Last updated: 2018-06-06

Locations

1 site across 1 country: Bolivia