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Completed

NCT Number: NCT02798120

P3 Long Term Safety Study of Once Daily SB204 in Acne

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CIL #138, Birmingham, Alabama, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB204 4%

Drug

Open label, topical SB204 4%

Other names: NVN1000

Primary outcomes

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

    Time frame: Baseline

    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.

  2. Number of Subjects With Treatment Emergent Adverse Events

    Time frame: Week 40/End of Treatment

    Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303.

Secondary outcomes

  1. Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)

    Time frame: Baseline, Week 4, Week 12, Week 24, Week 36, Week 40

    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.

  2. Inflammatory Lesion Counts by Study Visit

    Time frame: Baseline through Week 40

    Absolute count of inflammatory lesions at each visit (face only)--safety population

  3. Non-Inflammatory Lesion Counts by Study Visit

    Time frame: Baseline through Week 40

    Absolute count of non-inflammatory lesions by study visit (face only)

Sponsors and collaborators

Lead sponsor

Novan, Inc.

Industry

Collaborators

  • Chiltern International Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2016
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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