P3 Long Term Safety Study of Once Daily SB204 in Acne

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2017

Detailed Description

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

Interventions

  • Drug: SB204 4%
    • Open label, topical SB204 4%

Arms, Groups and Cohorts

  • Experimental: SB204 4%
    • SB204 4% once daily

Clinical Trial Outcome Measures

Primary Measures

  • safety assessments (Reported adverse events)
    • Time Frame: Week 40/End of Treatment
    • Reported adverse events

Secondary Measures

  • Tolerability assessment (Analysis of tolerability scores at each visit through end of treatment)
    • Time Frame: Week 40/End of Treatment
    • Analysis of tolerability scores at each visit through end of treatment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 9 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novan, Inc.
  • Collaborator
    • Chiltern International Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joyce Rico, Study Chair, Novan, Inc.

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