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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SB204 4%

SB204 8% or 12%

Vehicle

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Spaulding Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Placebo Comparator

Arm Label

SB204 4%

SB204 8% or 12 %

Moxifloxacillin

Vehicle Gel

Arm Description

SB204 4% once

SB204 8 or 12 % (supratherapeutic) once

Moxifloxacillin 400 mg orally

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02581072

First Posted

October 15, 2015

Last Updated

November 15, 2018

Sponsor

Novan, Inc.

Collaborators

Spaulding Clinical Research LLC

1. Study Identification

Unique Protocol Identification Number

NCT02581072

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novan, Inc.

Collaborators

Spaulding Clinical Research LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SB204 4%

Arm Type

Experimental

Arm Description

SB204 4% once

Arm Title

SB204 8% or 12 %

Arm Type

Experimental

Arm Description

SB204 8 or 12 % (supratherapeutic) once

Arm Title

Moxifloxacillin

Arm Type

No Intervention

Arm Description

Moxifloxacillin 400 mg orally

Arm Title

Vehicle Gel

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

SB204 4%

Other Intervention Name(s)

NVN1000

Intervention Description

Applied topically once

Intervention Type

Drug

Intervention Name(s)

SB204 8% or 12%

Other Intervention Name(s)

NVN1000

Intervention Description

Applied once topically

Intervention Type

Drug

Intervention Name(s)

Vehicle

Other Intervention Name(s)

Placebo

Intervention Description

Applied topically once

Primary Outcome Measure Information:

Title

Time Frame

15 days

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joyce Rico, MD

Organizational Affiliation

Novan, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spaulding Clinical Research, LLC

City

West Bend

State/Province

Wisconsin

ZIP/Postal Code

53095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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