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

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ClinicalTrials.gov Identifier: NCT02581072
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
Spaulding Clinical Research LLC
Information provided by (Responsible Party):
Novan, Inc.

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: SB204 4% Drug: SB204 8% or 12% Drug: Vehicle Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: SB204 4%
SB204 4% once
Drug: SB204 4%
Applied topically once
Other Name: NVN1000

Experimental: SB204 8% or 12 %
SB204 8 or 12 % (supratherapeutic) once
Drug: SB204 8% or 12%
Applied once topically
Other Name: NVN1000

No Intervention: Moxifloxacillin
Moxifloxacillin 400 mg orally
Placebo Comparator: Vehicle Gel
Placebo
Drug: Vehicle
Applied topically once
Other Name: Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581072


Locations
United States, Wisconsin
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Novan, Inc.
Spaulding Clinical Research LLC
Investigators
Principal Investigator: Joyce Rico, MD Novan, Inc.

Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT02581072     History of Changes
Other Study ID Numbers: NI-AC104
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases