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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novan, Inc.
• Collaborator: Spaulding Clinical Research LLC
• Treatments: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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