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

Sexually Transmitted Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535104
• Other study ID #: TAMIR1501HPV
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Tamir Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Condylomata Acuminata
• Papillomavirus Infections
• Sexually Transmitted Diseases

Intervention

Drug:
• Ranpirnase
Topical application by subject
• Vehicle
Vehicle control

Locations

Country	Name	City	State
Bolivia	IDH	Cochabamba

Sponsors (1)

Lead Sponsor	Collaborator
Tamir Biotechnology, Inc.

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of lesions	The primary endpoint is the percentage change from baseline in total area of lesions at Week 8	Up to 60 days
Secondary	Number of lesions	Number of lesions present at Week 8	Up to 60 days