A Phase 1/2 interventional study of Ranpirnase and Vehicle in Condylomata Acuminata, Papillomavirus Infections and Sexually Transmitted Diseases, sponsored by Tamir Biotechnology, Inc.. Completed at 1 site in Bolivia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Tamir Biotechnology, Inc. · Phase 1/2, Interventional, and Treatment
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.
116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.
This study's enrollment of 70 is below the median of 158 across 95 interventional studies indexed under Condylomata Acuminata.
Browse Condylomata Acuminata studies →Tamir Biotechnology, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 mg/ml solution of ranpirnase applied twice daily
Drug: Ranpirnase
Vehicle - innert gel
Drug: Vehicle
Topical application by subject
Also known as: Onconase
Vehicle control
Also known as: Placebo
Size of lesions
The primary endpoint is the percentage change from baseline in total area of lesions at Week 8
Time frame: Up to 60 days
Number of lesions
Number of lesions present at Week 8
Time frame: Up to 60 days
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Feb 2016, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Tamir Biotechnology, Inc.