Spots Global Cancer Trial Database for Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)

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Trial Identification

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

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 ID: NCT02535104

Conditions

Condylomata Acuminata

Papillomavirus Infections

Sexually Transmitted Diseases

Interventions

Ranpirnase

Vehicle

Study Description

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.

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.