Topical NVN1000 for the Treatment of External Genital and Perianal Warts

Study Overview
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Brief Summary
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A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts

Detailed Description
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This is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose study to assess safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects with external genital and perianal warts. Eligible subjects will be treated with a topical gel (active or vehicle) for up to 12 weeks.

Official Title
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A Phase 2, Multi-center, Double-blind, Randomized, Vehicle-controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects With External Genital Warts and Perianal Warts

Conditions
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Genital Warts, Perianal Warts

Intervention / Treatment
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* Drug: NVN1000 8% Gel
* Drug: NVN1000 16%
* Drug: Vehicle
* Drug: NVN1000 24%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 2 but not more than 20 genital/perianal warts with a maximum total wart surface area no more than 1% body surface area If a woman of child-bearing potential, have a negative pregnancy test and use effective contraception If currently receiving wart treatment, be willing to stop all treatment for 28 days prior to randomization and during the study Exclusion Criteria: Immunocompromised patients including those with HIV, receiving radiation, or drugs that suppress the immune system Pregnant, planning to become pregnant, or nursing History of cancer (including cervical cancer) within 5 years, with exception of non-melanoma skin cancer in non-genital skin Recent history of other genital skin infections Active HSV and frequent HSV recurrences unless receiving suppression therapy Have hemoglobin < 10 G/dl or methemoglobin > 3% Known allergy to any component of the gel including excipients Previously participated in any study with NVN1000 or SB204

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVN1000 8% Gel twice daily<br>NVN1000 8% Gel twice daily | Drug: NVN1000 8% Gel<br>* once and twice daily<br>* Other names: SB206;|
| Experimental: NVN1000 8% Gel once daily<br>NVN1000 8% Gel once daily | Drug: NVN1000 8% Gel<br>* once and twice daily<br>* Other names: SB206;|
| Experimental: NVN1000 16% Once daily<br>NVN1000 16% Gel once daily | Drug: NVN1000 16%<br>* once daily<br>* Other names: SB206;|
| Placebo Comparator: Vehicle Gel<br>Vehicle Gel at frequency to match active | Drug: Vehicle<br>* placebo comparator<br>* Other names: Placebo;|
| Experimental: NVN1000 24% once daily<br>NVN1000 24% once daily | Drug: NVN1000 24%<br>* once daily<br>* Other names: SB206;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 | Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch | Comparison of scores for erythema, edema, erosions/ulcers, itch between active and vehicle treated subjects using a 4 point grading scale; on the tolerability scale, 0 = none and 3 = severe, indicating an increase in severity the higher the number assigned. | Baseline, Week 2, Week 4, Week 8, Week 12 | 
| Safety as Determined by Changes in Laboratory Assessments | Safety population--Comparison of changes in methemoglobin levels between active and vehicle treated subjects. Methemoglobin levels were measured using a RAD-57 pulse co-oximeter. Values are expressed as a percentage of hemoglobin. | Baseline, Week 2 and Week 12 | 
| Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12 | The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator | 12 weeks | 
| Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12 | Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genital warts, perianal warts