Back to results

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

Primary Purpose

Condylomata Acuminata, Papillomavirus Infections, Sexually Transmitted Diseases

Status

Completed

Phase

Phase 1

Locations

Bolivia

Study Type

Interventional

Intervention

Ranpirnase

Vehicle

About this trial

This is an interventional treatment trial for Condylomata Acuminata

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 lesions
Accept to follow study instructions / signature of IC
Abstain from sexual intercourse for 6 hours after applying the study product during the time of the study.

Exclusion Criteria:

Any topical and/or destructive treatments for external genital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrollment (i.e., the randomization visit)
Non pregnant. For women in reproductive age it would be required pregnancy test, and the use of double barrier contraceptives.
Any of the following conditions:
Known allergy to the study product
Internal (rectal, urethral) warts that required or were undergoing treatment;
A dermatological disease (e.g., psoriasis) or skin condition in the area, which may interfere with the evaluation.
Imiquimod 5% cream (Aldara®)
Any marketed or investigational HPV vaccines
Sinecatechins (Veregen)
Interferon or interferon inducers
Cytotoxic drugs
Immunomodulators or immunosuppressives
Oral or parenteral corticosteroids (inhaled/intranasal steroids are permitted)
Oral antiviral drugs (with the exception of HAART, oral acyclovir and acyclovir related drugs) for suppressive or acute therapy herpes; or oseltamivir for prophylaxis or for influenza)
Topical antiviral drugs (including topical acyclovir and acyclovir related drugs) in the areas under treatment
Podophyllotoxin/Podofilox in the treatment areas
Any topical prescription medications in the treatment areas
Dermatologic procedures or surgery in the treatment areas

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control

Arm Description

1 mg/ml solution of ranpirnase applied twice daily

Vehicle - innert gel

Outcomes

Primary Outcome Measures

Size of lesions

The primary endpoint is the percentage change from baseline in total area of lesions at Week 8

Secondary Outcome Measures

Number of lesions

Number of lesions present at Week 8

Full Information

NCT ID

NCT02535104

First Posted

August 22, 2015

Last Updated

June 4, 2018

Sponsor

Tamir Biotechnology, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02535104

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tamir Biotechnology, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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 Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Condylomata Acuminata, Papillomavirus Infections, Sexually Transmitted Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

1 mg/ml solution of ranpirnase applied twice daily

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Vehicle - innert gel

Intervention Type

Drug

Intervention Name(s)

Ranpirnase

Other Intervention Name(s)

Onconase

Intervention Description

Topical application by subject

Intervention Type

Drug

Intervention Name(s)

Vehicle

Other Intervention Name(s)

Placebo

Intervention Description

Vehicle control

Primary Outcome Measure Information:

Title

Size of lesions

Description

The primary endpoint is the percentage change from baseline in total area of lesions at Week 8

Time Frame

Up to 60 days

Secondary Outcome Measure Information:

Title

Number of lesions

Description

Number of lesions present at Week 8

Time Frame

Up to 60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 lesions Accept to follow study instructions / signature of IC Abstain from sexual intercourse for 6 hours after applying the study product during the time of the study. Exclusion Criteria: Any topical and/or destructive treatments for external genital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrollment (i.e., the randomization visit) Non pregnant. For women in reproductive age it would be required pregnancy test, and the use of double barrier contraceptives. Any of the following conditions: Known allergy to the study product Internal (rectal, urethral) warts that required or were undergoing treatment; A dermatological disease (e.g., psoriasis) or skin condition in the area, which may interfere with the evaluation. Imiquimod 5% cream (Aldara®) Any marketed or investigational HPV vaccines Sinecatechins (Veregen) Interferon or interferon inducers Cytotoxic drugs Immunomodulators or immunosuppressives Oral or parenteral corticosteroids (inhaled/intranasal steroids are permitted) Oral antiviral drugs (with the exception of HAART, oral acyclovir and acyclovir related drugs) for suppressive or acute therapy herpes; or oseltamivir for prophylaxis or for influenza) Topical antiviral drugs (including topical acyclovir and acyclovir related drugs) in the areas under treatment Podophyllotoxin/Podofilox in the treatment areas Any topical prescription medications in the treatment areas Dermatologic procedures or surgery in the treatment areas

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edgar Valdez, MD

Organizational Affiliation

Director - Research site

Official's Role

Study Chair

Facility Information:

Facility Name

IDH

City

Cochabamba

Country

Bolivia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs