A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204
NCT02581072 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2018-11-19
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
Conditions
- Acne Vulgaris
Interventions
- DRUG
-
SB204 4%
Applied topically once
- DRUG
-
SB204 8% or 12%
Applied once topically
- DRUG
-
Vehicle
Applied topically once
Sponsors & Collaborators
-
Spaulding Clinical Research LLC
collaborator OTHER -
Novan, Inc.
lead INDUSTRY
Principal Investigators
-
Joyce Rico, MD · Novan, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2015-12-31
- Completion
- 2016-04-30
Countries
- United States
Study Locations
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