P3 Long Term Safety Study of Once Daily SB204 in Acne

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: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: SB204 4%

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: Interventional
• Enrollment (Actual): 601
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Novan, Inc.
• Collaborators: Chiltern International Inc.
• Investigators: Study Chair: Joyce Rico, Novan, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 27, 2017

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: NI-AC303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO