A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204
Phase 1
Completed
- Conditions
- Acne Vulgaris
- Interventions
- Drug: SB204 4%Drug: SB204 8% or 12%Drug: Vehicle
- Registration Number
- NCT02581072
- Lead Sponsor
- 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SB204 4% SB204 4% SB204 4% once SB204 8% or 12 % SB204 8% or 12% SB204 8 or 12 % (supratherapeutic) once Vehicle Gel Vehicle Placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Spaulding Clinical Research, LLC
🇺🇸West Bend, Wisconsin, United States