- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02535104
Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Cochabamba, Bolivia
- IDH
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
1 mg/ml solution of ranpirnase applied twice daily
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Topical application by subject
Other Names:
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Placebo Comparator: Control
Vehicle - innert gel
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Vehicle control
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Size of lesions
Time Frame: Up to 60 days
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The primary endpoint is the percentage change from baseline in total area of lesions at Week 8
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Up to 60 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of lesions
Time Frame: Up to 60 days
|
Number of lesions present at Week 8
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Up to 60 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Edgar Valdez, MD, Director - Research site
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Disease Attributes
- DNA Virus Infections
- Skin Diseases, Infectious
- Warts
- Skin Diseases, Viral
- Tumor Virus Infections
- Sexually Transmitted Diseases
- Papillomavirus Infections
- Condylomata Acuminata
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Synthesis Inhibitors
- Ranpirnase
Other Study ID Numbers
- TAMIR1501HPV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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