Clinical trial NCT02462187: Topical NVN1000 for the Treatment of External Genital and Perianal Warts
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Genital Warts
Perianal Warts
Keywords: genital warts
perianal warts
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2015-06-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Safety as Determined by Changes in Laboratory Assessments
timeFrame: Baseline, Week 2 and Week 12
measure: Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12
timeFrame: 12 weeks
measure: Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: PPD 137
state: California
city: Lomita
country: United States
facility: PPD 140
state: California
city: San Diego
country: United States
facility: PPD 133
state: California
city: Atlanta
country: United States
facility: PPD 134
state: Georgia
city: Atlanta
country: United States
facility: PPD 139
state: Georgia
city: Roswell
country: United States
facility: PPD 138
state: Georgia
city: Indianapolis
country: United States
facility: PPD 130
state: Indiana
city: Metairie
country: United States
facility: PPD 126
state: Louisiana
city: Portland
country: United States
facility: PPD 132
state: Oregon
city: Philadelphia
country: United States
facility: PPD 135
state: Pennsylvania
city: Corpus Christi
country: United States
facility: PPD 128
state: Texas
city: Houston
country: United States
facility: PPD 129
state: Texas
city: San Antonio
country: United States
facility: PPD 127
state: Texas
city: Webster
country: United States
facility: PPD 131
state: Texas
city: Seattle
country: United States
facility: PPD 136
state: Washington
Study officials:
affiliation: Novan, Inc.
name: Joyce Rico, MD
role: STUDY_DIRECTOR
References: