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
1 other identifier
interventional
601
1 country
69
Brief Summary
This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2016
Shorter than P25 for phase_3
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 12, 2016
CompletedFirst Submitted
Initial submission to the registry
June 9, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2017
CompletedResults Posted
Study results publicly available
May 12, 2023
CompletedMay 12, 2023
May 1, 2023
11 months
June 9, 2016
January 25, 2023
May 10, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline, Week 4, Week 12, Week 24, Week 36, Week 40
Inflammatory Lesion Counts by Study Visit
Baseline through Week 40
Non-Inflammatory Lesion Counts by Study Visit
Baseline through Week 40
Study Arms (1)
SB204 4%
EXPERIMENTALAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- Have completed 12 weeks of treatment in NI-AC301 or NI-AC302
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novan, Inc.lead
- Chiltern International Inc.collaborator
Study Sites (69)
CIL #138
Birmingham, Alabama, 35202, United States
CIL #218
Mobile, Alabama, 36608, United States
CIL #189
Phoenix, Arizona, 85018, United States
CIL #146
Anaheim, California, 92801, United States
CIL #139
Cerritos, California, 90703, United States
CIL #216
Chula Vista, California, 91911, United States
CIL #186
Fresno, California, 93720, United States
CIL #210
Fresno, California, 93720, United States
CIL #174
Huntington Beach, California, 92647, United States
CIL #213
La Mesa, California, 91942, United States
CIL #209
Oceanside, California, 92056, United States
CIL #190
Sacramento, California, 95821, United States
CIL #161
San Diego, California, 92103, United States
CIL #113
San Diego, California, 92123, United States
CIL #195
Santa Ana, California, 92705, United States
CIL #119
Santa Monica, California, 90404, United States
CIL #199
Santa Rosa, California, 95405, United States
CIL #103
Boca Raton, Florida, 33486, United States
CIL #208
Hialeah, Florida, 33012, United States
CIL #212
Homestead, Florida, 33030, United States
CIL #222
Lauderdale Lakes, Florida, 33406, United States
CIL #170
Miami Lakes, Florida, 33016, United States
CIL #204
Miami Springs, Florida, 33166, United States
CIL #172
Orlando, Florida, 32814, United States
CIL #185
Ormond Beach, Florida, 32174, United States
CIL #203
Ormond Beach, Florida, 32174, United States
CIL #110
Pinellas Park, Florida, 33781, United States
CIL #227
Sanford, Florida, 32771, United States
CIL #211
South Miami, Florida, 33413, United States
CIL #176
St. Petersburg, Florida, 33716, United States
CIL #152
Tampa, Florida, 33607, United States
CIL #229
Tampa, Florida, 33609, United States
CIL #144
Tampa, Florida, 33634, United States
CIL #153
Wellington, Florida, 33414, United States
CIL #116
Newnan, Georgia, 30263, United States
CIL #143
Savannah, Georgia, 31406, United States
CIL #175
New Albany, Indiana, 47150, United States
CIL #191
Overland Park, Kansas, 66215, United States
CIL #215
Wichita, Kansas, 67207, United States
CIL #117
Louisville, Kentucky, 40202, United States
CIL #194
Richmond, Kentucky, 40475, United States
CIL #219
Monroe, Louisiana, 71203, United States
CIL #187
St Louis, Missouri, 63141, United States
CIL #148
Norfolk, Nebraska, 68701, United States
CIL #140
Omaha, Nebraska, 68134, United States
CIL #182
Las Vegas, Nevada, 89129, United States
CIL #201
Berlin, New Jersey, 08009, United States
CIL #141
Montclair, New Jersey, 07042, United States
CIL #156
Albuquerque, New Mexico, 87102, United States
CIL #108
Rochester, New York, 14623, United States
CIL #221
Salisbury, North Carolina, 28144, United States
CIL #169
Cincinnati, Ohio, 45246, United States
CIL #226
Cincinnati, Ohio, 45255, United States
CIL #237
Gresham, Oregon, 97030, United States
CIL #200
Portland, Oregon, 97210, United States
CIL #137
Broomall, Pennsylvania, 19008, United States
CIL #178
Philadelphia, Pennsylvania, 19103, United States
CIL #217
Chattanooga, Tennessee, 37421, United States
CIL #198
Arlington, Texas, 76011, United States
CIL #160
Austin, Texas, 78735, United States
CIL #154
Beaumont, Texas, 77701, United States
CIL #184
Bryan, Texas, 77802, United States
CIL #188
Houston, Texas, 77055, United States
CIL #151
Plano, Texas, 75093, United States
CIL #168
Plano, Texas, 75234, United States
CIL #224
San Antonio, Texas, 78218, United States
CIL #106
Salt Lake City, Utah, 84117, United States
CIL #105
Lynchburg, Virginia, 24501, United States
CIL #231
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cathy White, Vice President, Drug Development Operations
- Organization
- Novan
Study Officials
- STUDY CHAIR
Joyce Rico
Novan, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2016
First Posted
June 14, 2016
Study Start
May 12, 2016
Primary Completion
April 1, 2017
Study Completion
April 27, 2017
Last Updated
May 12, 2023
Results First Posted
May 12, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share