A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204
NCT ID: NCT02581072
Last Updated: 2018-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2015-10-31
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 1 Study Assessing Local Cutaneous Effects of SB204
NCT02250430
Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
NCT02801903
Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne
NCT02998671
P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris
NCT02242760
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
NCT07013747
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SB204 4%
SB204 4% once
SB204 4%
Applied topically once
SB204 8% or 12 %
SB204 8 or 12 % (supratherapeutic) once
SB204 8% or 12%
Applied once topically
Moxifloxacillin
Moxifloxacillin 400 mg orally
No interventions assigned to this group
Vehicle Gel
Placebo
Vehicle
Applied topically once
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SB204 4%
Applied topically once
SB204 8% or 12%
Applied once topically
Vehicle
Applied topically once
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 20 inflammatory and 25 non-inflammatory acne lesions
Exclusion Criteria
* Known allergy to any component of the topical SB204 formulation
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Spaulding Clinical Research LLC
OTHER
Novan, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joyce Rico, MD
Role: PRINCIPAL_INVESTIGATOR
Novan, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NI-AC104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.