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

Novan, Inc.56 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acne Vulgaris

Interventions

SB204 4%DRUG

Applied topically once

SB204 8% or 12%DRUG

Applied once topically

VehicleDRUG

Applied topically once

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Spaulding Clinical Research, LLC

West Bend, Wisconsin, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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