Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02535104|
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Condylomata Acuminata Papillomavirus Infections Sexually Transmitted Diseases||Drug: Ranpirnase Drug: Vehicle||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||February 2016|
|Primary Completion Date :||September 2016|
|Study Completion Date :||September 2016|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02535104
|Study Chair:||Edgar Valdez, MD||Director - Research site|