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

NCT ID: NCT02535104

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-09-30

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.

Conditions

Condylomata Acuminata; Papillomavirus Infections; Sexually Transmitted Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group

1 mg/ml solution of ranpirnase applied twice daily

Group Type: EXPERIMENTAL

Ranpirnase

Intervention Type: DRUG

Topical application by subject

Control

Vehicle - innert gel

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle control

Interventions

Ranpirnase

Topical application by subject

Intervention Type: DRUG

Vehicle

Vehicle control

Intervention Type: DRUG

Other Intervention Names

Onconase; Placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tamir Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edgar Valdez, MD

Role: STUDY_CHAIR

Director - Research site

Locations

IDH

Cochabamba, , Bolivia

Countries

Bolivia

Other Identifiers

TAMIR1501HPV

Identifier Type: -

Identifier Source: org_study_id