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

Novan

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: SB204 4%; Drug: Vehicle; Drug: SB204 8% or 12%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02581072

NI-AC104

Details and patient eligibility

About

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

Full 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

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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56 participants in 4 patient groups, including a placebo group

SB204 4%

Experimental group

Description:

SB204 4% once

Treatment:

Drug: SB204 4%

SB204 8% or 12 %

Experimental group

Description:

SB204 8 or 12 % (supratherapeutic) once

Treatment:

Drug: SB204 8% or 12%

Moxifloxacillin

No Intervention group

Description:

Moxifloxacillin 400 mg orally

Vehicle Gel

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Vehicle