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Completed

NCT Number: NCT02462187

Topical NVN1000 for the Treatment of External Genital and Perianal Warts

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

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Key information

Conditions

Genital Warts Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Perianal Warts Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PPD 137, Fountain Valley, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NVN1000 8% Gel

Drug

once and twice daily

Other names: SB206

NVN1000 16%

Drug

once daily

Other names: SB206

Vehicle

Drug

placebo comparator

Other names: Placebo

NVN1000 24%

Drug

once daily

Other names: SB206

Primary outcomes

  1. 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

  1. Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch

    Time frame: Baseline, Week 2, Week 4, Week 8, Week 12

    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.

  2. Safety as Determined by Changes in Laboratory Assessments

    Time frame: Baseline, Week 2 and Week 12

    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.

  3. Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12

    Time frame: 12 weeks

    The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator

  4. Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12

    Time frame: 12 weeks

    Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator

Sponsors and collaborators

Lead sponsor

Novan, Inc.

Industry

Collaborators

  • PPD Development, LP

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2015
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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