Sexually Transmitted Diseases Clinical Trial
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
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.
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.
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