Clinical trial

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

Name

NI-AC303

Description

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

Trial arms

Trial start

2016-05-12

Estimated PCD

2017-04-01

Trial end

2017-04-27

Status

Completed

Phase

Early phase I

Treatment

SB204 4%

Open label, topical SB204 4%

Arms:

SB204 4%

Other names:

NVN1000

Size

601

Primary endpoint

Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)

Baseline

Number of Subjects With Treatment Emergent Adverse Events

Week 40/End of Treatment

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 601, 'type': 'ACTUAL'}}

Updated at

2023-05-12

1 organization

1 product

1 indication

Organization

Novan

Product

SB204

Indication

Acne Vulgaris