P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

Novan

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Vehicle Gel; Drug: SB204 4%; Drug: SB204 2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02242760

NI-AC202

Details and patient eligibility

About

This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Full description

A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Enrollment: 213 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe acne
• 25-70 non-inflammatory lesions at Baseline
• 20-40 inflammatory lesions at Baseline

Exclusion criteria

• Subjects with known allergy to any component of the test material or vehicle
• Women who are pregnant or nursing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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213 participants in 5 patient groups, including a placebo group

SB204 2% Twice daily

Experimental group

Description:

Twice daily SB204 2%

Treatment:

Drug: SB204 2%

SB204 4% daily

Experimental group

Description:

Once daily SB204 4%

Treatment:

Drug: SB204 4%

Vehicle Gel Daily

Placebo Comparator group

Description:

Vehicle Gel Daily

Treatment:

Drug: Vehicle Gel

Vehicle Gel Twice Daily

Placebo Comparator group

Description:

Twice daily Vehicle Gel

Treatment:

Drug: Vehicle Gel

SB204 4% Twice Daily

Experimental group

Description:

Twice daily SB204 4%

Treatment:

Drug: SB204 4%