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Completed

NCT Number: NCT02581072

A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204

A Double-Blind, Double-Dummy, Randomized, 4-Period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Spaulding Clinical Research, LLC

West Bend, Wisconsin, 53095, United States

About this study

A Double-Blind, Double-Dummy, Randomized, 4-Period, Crossover Study to Define the ECG Effects of SB204 Using a Clinical and a Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate to severe acne
  • 20 inflammatory and 25 non-inflammatory acne lesions

Exclusion criteria

  • Pregnant, trying to become pregnant, or nursing
  • Known allergy to any component of the topical SB204 formulation

Treatment and study plan

SB204 4%

Drug

Applied topically once

Other names: NVN1000

SB204 8% or 12%

Drug

Applied once topically

Other names: NVN1000

Vehicle

Drug

Applied topically once

Other names: Placebo

Primary outcomes

  1. Define ECG effect of SB204 at therapeutic and supratherapeutic dose concentrations as measured by the difference between time-matched baseline adjusted QTcF interval for the groups recieving SB204 and placebo.

    Time frame: 15 days

Secondary outcomes

  1. Categorical analysis of the QTc interval to determine number and percentage of time points and subjects by dose group with absolute QT/QTc > 450, 480, and 500 ms.

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Novan, Inc.

Industry

Collaborators

  • Spaulding Clinical Research LLC

Registry information

Official study title

A Double-blind, Double-dummy, Randomized, 4-period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared With Placebo and Moxifloxacin in Subjects With Acne Vulgaris: A Thorough ECG STudy

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Oct 20, 2015
Registry last updated
Nov 19, 2018

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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