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
Overview
- Phase
- Phase 2
- Intervention
- NVN1000 8% Gel
- Conditions
- Genital Warts
- Sponsor
- Novan, Inc.
- Enrollment
- 108
- Locations
- 15
- Primary Endpoint
- Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
NVN1000 8% Gel twice daily
NVN1000 8% Gel twice daily
Intervention: NVN1000 8% Gel
NVN1000 8% Gel once daily
NVN1000 8% Gel once daily
Intervention: NVN1000 8% Gel
NVN1000 16% Once daily
NVN1000 16% Gel once daily
Intervention: NVN1000 16%
Vehicle Gel
Vehicle Gel at frequency to match active
Intervention: Vehicle
NVN1000 24% once daily
NVN1000 24% once daily
Intervention: NVN1000 24%
Outcomes
Primary Outcomes
Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12
Time Frame: 12 weeks
Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.
Secondary Outcomes
- Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch(Baseline, Week 2, Week 4, Week 8, Week 12)
- Safety as Determined by Changes in Laboratory Assessments(Baseline, Week 2 and Week 12)
- Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12(12 weeks)
- Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12(12 weeks)