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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 -

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 Summary:

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.


Sponsor: Tamir Biotechnology, Inc.

Current Primary Outcome: 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


Original Primary Outcome:

  • Size of lesions [ Time Frame: Up to 60 days ]
    Modification of the number of lesions compared with baseline. This include a 0 (no change) to 3 (complete clearance).
  • Number of lesions [ Time Frame: Up to 60 days ]
    Modification of the number of lesions compared with baseline. This include a 0 (no change) to 3 (complete clearance).


Current Secondary Outcome: Number of lesions [ Time Frame: Up to 60 days ]

Number of lesions present at Week 8


Original Secondary Outcome:

  • Skin reactivity / Inflammatory response [ Time Frame: Up to 60 days ]
    Combined scores of erythema, edema, blistering to measure irritation. Every item will be scored from 0 (no change) to 3 (severe). Participants with a score = 3 will be considered as a severe adverse event.
  • Symptoms [ Time Frame: Up to 60 days ]
    Evaluation of itching and pain in a subjective scale according with the experience of the participant will be measured from 0 (absent) to 3 (severe)


Information By: Tamir Biotechnology, Inc.

Dates:
Date Received: August 22, 2015
Date Started: February 2016
Date Completion:
Last Updated: March 28, 2017
Last Verified: March 2017