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

Tamir Biotechnology

Status and phase

Completed

Phase 2

Phase 1

Conditions

Sexually Transmitted Diseases

Condylomata Acuminata

Papillomavirus Infections

Treatments

Drug: Ranpirnase

Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT02535104

TAMIR1501HPV

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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