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NCT02581072 Clinical Trial

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

Acne Vulgaris Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02581072
Other study ID # NI-AC104
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2015
Est. completion date April 2016

Study information
Verified date November 2018
Source Novan, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date April 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SB204 4%
Applied topically once
• SB204 8% or 12%
Applied once topically
• Vehicle
Applied topically once

Locations
Country Name City State
United States Spaulding Clinical Research, LLC West Bend Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
Novan, Inc. Spaulding Clinical Research LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 15 days
Secondary 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. 15 days
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