Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)
|Condylomata Acuminata Papillomavirus Infections Sexually Transmitted Diseases||Drug: Ranpirnase Drug: Vehicle||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- 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
- Number of lesions [ Time Frame: Up to 60 days ]Number of lesions present at Week 8
|Study Start Date:||February 2016|
|Study Completion Date:||September 2016|
|Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment group
1 mg/ml solution of ranpirnase applied twice daily
Topical application by subject
Other Name: Onconase
Placebo Comparator: Control
Vehicle - innert gel
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02535104
|Study Chair:||Edgar Valdez, MD||Director - Research site|