P3 Long Term Safety Study of Once Daily SB204 in Acne

May 10, 2023 updated by: Novan, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
601

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35202
        • CIL #138
      • Mobile, Alabama, United States, 36608
        • CIL #218
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • CIL #189
    • California
      • Anaheim, California, United States, 92801
        • CIL #146
      • Cerritos, California, United States, 90703
        • CIL #139
      • Chula Vista, California, United States, 91911
        • CIL #216
      • Fresno, California, United States, 93720
        • CIL #186
      • Fresno, California, United States, 93720
        • CIL #210
      • Huntington Beach, California, United States, 92647
        • CIL #174
      • La Mesa, California, United States, 91942
        • CIL #213
      • Oceanside, California, United States, 92056
        • CIL #209
      • Sacramento, California, United States, 95821
        • CIL #190
      • San Diego, California, United States, 92103
        • CIL #161
      • San Diego, California, United States, 92123
        • CIL #113
      • Santa Ana, California, United States, 92705
        • CIL #195
      • Santa Monica, California, United States, 90404
        • CIL #119
      • Santa Rosa, California, United States, 95405
        • CIL #199
    • Florida
      • Boca Raton, Florida, United States, 33486
        • CIL #103
      • Hialeah, Florida, United States, 33012
        • CIL #208
      • Homestead, Florida, United States, 33030
        • CIL #212
      • Lauderdale Lakes, Florida, United States, 33406
        • CIL #222
      • Miami Lakes, Florida, United States, 33016
        • CIL #170
      • Miami Springs, Florida, United States, 33166
        • CIL #204
      • Orlando, Florida, United States, 32814
        • CIL #172
      • Ormond Beach, Florida, United States, 32174
        • CIL #185
      • Ormond Beach, Florida, United States, 32174
        • CIL #203
      • Pinellas Park, Florida, United States, 33781
        • CIL #110
      • Saint Petersburg, Florida, United States, 33716
        • CIL #176
      • Sanford, Florida, United States, 32771
        • CIL #227
      • South Miami, Florida, United States, 33413
        • CIL #211
      • Tampa, Florida, United States, 33607
        • CIL #152
      • Tampa, Florida, United States, 33609
        • CIL #229
      • Tampa, Florida, United States, 33634
        • CIL #144
      • Wellington, Florida, United States, 33414
        • CIL #153
    • Georgia
      • Newnan, Georgia, United States, 30263
        • CIL #116
      • Savannah, Georgia, United States, 31406
        • CIL #143
    • Indiana
      • New Albany, Indiana, United States, 47150
        • CIL #175
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • CIL #191
      • Wichita, Kansas, United States, 67207
        • CIL #215
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • CIL #117
      • Richmond, Kentucky, United States, 40475
        • CIL #194
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • CIL #219
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • CIL #187
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • CIL #148
      • Omaha, Nebraska, United States, 68134
        • CIL #140
    • Nevada
      • Las Vegas, Nevada, United States, 89129
        • CIL #182
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • CIL #201
      • Montclair, New Jersey, United States, 07042
        • CIL #141
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • CIL #156
    • New York
      • Rochester, New York, United States, 14623
        • CIL #108
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • CIL #221
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • CIL #169
      • Cincinnati, Ohio, United States, 45255
        • CIL #226
    • Oregon
      • Gresham, Oregon, United States, 97030
        • CIL #237
      • Portland, Oregon, United States, 97210
        • CIL #200
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • CIL #137
      • Philadelphia, Pennsylvania, United States, 19103
        • CIL #178
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • CIL #217
    • Texas
      • Arlington, Texas, United States, 76011
        • CIL #198
      • Austin, Texas, United States, 78735
        • CIL #160
      • Beaumont, Texas, United States, 77701
        • CIL #154
      • Bryan, Texas, United States, 77802
        • CIL #184
      • Houston, Texas, United States, 77055
        • CIL #188
      • Plano, Texas, United States, 75093
        • CIL #151
      • Plano, Texas, United States, 75234
        • CIL #168
      • San Antonio, Texas, United States, 78218
        • CIL #224
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • CIL #106
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • CIL #105
      • Norfolk, Virginia, United States, 23507
        • CIL #231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SB204 4%
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%
Open label, topical SB204 4%
Other Names:
  • NVN1000

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Week 40/End of Treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, Week 12, Week 24, Week 36, Week 40
Inflammatory Lesion Counts by Study Visit
Time Frame: Baseline through Week 40
Absolute count of inflammatory lesions at each visit (face only)--safety population
Baseline through Week 40
Non-Inflammatory Lesion Counts by Study Visit
Time Frame: Baseline through Week 40
Absolute count of non-inflammatory lesions by study visit (face only)
Baseline through Week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novan, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chiltern International Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Joyce Rico, Novan, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NI-AC303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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