NCT02581072

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

October 15, 2015

Last Update Submit

November 15, 2018

Conditions

Acne Vulgaris

Outcome Measures

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.

    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.

    15 days

Study Arms (4)

SB204 4%

EXPERIMENTAL

SB204 4% once

Drug: SB204 4%

SB204 8% or 12 %

EXPERIMENTAL

SB204 8 or 12 % (supratherapeutic) once

Drug: SB204 8% or 12%

Moxifloxacillin

NO INTERVENTION

Moxifloxacillin 400 mg orally

Vehicle Gel

PLACEBO COMPARATOR

Placebo

Drug: Vehicle

Interventions

SB204 4%DRUG

Applied topically once

Also known as: NVN1000
SB204 4%
SB204 8% or 12%DRUG

Applied once topically

Also known as: NVN1000
SB204 8% or 12 %
VehicleDRUG

Applied topically once

Also known as: Placebo
Vehicle Gel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Clinical Research, LLC

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

berdazimer sodium

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Joyce Rico, MD

    Novan, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 20, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

November 19, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)