P3 Long Term Safety Study of Once Daily SB204 in Acne

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

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

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: SB204 4%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB204 4%<br>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. | Drug: SB204 4%<br>* Open label, topical SB204 4%<br>* Other names: NVN1000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303) | This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive. | Baseline | 
| Number of Subjects With Treatment Emergent Adverse Events | Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303. | Week 40/End of Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Analysis of cutaneous tolerability scores at each visit through end of treatment. Baseline is the Week 12 assessment from the previous study (NI-AC301 or NI-AC302). The Cutaneous Tolerability Assessment scale consisted of the investigator's assessment of erythema, scaling, and dryness at the time the assessment was made. Pruritus and burning/stinging were based on the subject's report for the previous 24 hours. Each component was graded on a scale of 0-3, with 0 being none (not present) and 3 being severe. Higher scores indicated a higher severity of reaction. | Baseline, Week 4, Week 12, Week 24, Week 36, Week 40 | 
| Inflammatory Lesion Counts by Study Visit | Absolute count of inflammatory lesions at each visit (face only)--safety population | Baseline through Week 40 | 
| Non-Inflammatory Lesion Counts by Study Visit | Absolute count of non-inflammatory lesions by study visit (face only) | Baseline through Week 40 |