P3 Long Term Safety Study of Once Daily SB204 in Acne

Novan

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: SB204 4%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02798120

NI-AC303

Details and patient eligibility

About

This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.

Full description

A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris.

Enrollment: 601 patients

Sex: All

Ages: 9 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed 12 weeks of treatment in NI-AC301 or NI-AC302

Exclusion criteria

• Terminated early from an SB204 Phase 3 pivotal study for any reason
• Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application
• Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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601 participants in 1 patient group

SB204 4%

Experimental group

Description:

All subjects received SB204 4% once daily (QD) in this open label study. Subjects assigned to SB204 4% QD in the parent study (NI-AC301/302) continued to receive SB204 for 40 more weeks. Subjects assigned to Vehicle Gel in the parent study (NI-AC301/302) received SB204 4% QD in this open label study.

Treatment:

Drug: SB204 4%