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CompletedNCT02798120Updated May 12, 2023Results posted

P3 Long Term Safety Study of Once Daily SB204 in Acne

A Phase 3 interventional study of SB204 4% in Acne Vulgaris, sponsored by Novan, Inc.. Completed at 69 sites in United States. Open to participants aged 9 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by Novan, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
601
Allocation
Not applicable
Ages
9 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

This study's enrollment of 601 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Novan, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Browse Novan, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have completed 12 weeks of treatment in NI-AC301 or NI-AC302

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
601 participants (actual)

Study arms

  • 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%

Interventions

  • DrugSB204 4%

    Open label, topical SB204 4%

    Also known as: NVN1000

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Week 40/End of Treatment

Secondary outcomes

  1. 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.

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

  2. Inflammatory Lesion Counts by Study Visit

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

    Time frame: Baseline through Week 40

  3. Non-Inflammatory Lesion Counts by Study Visit

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

    Time frame: Baseline through Week 40

07

Results

Posted May 12, 2023

Participant flow

Subjects who successfully completed one of the pivotal parent studies NI-AC301 and NI-AC302 were eligible to roll over into NI-AC303. Those subjects assigned to SB204 once daily (QD) in the parent study continued to receive open label SB204 for 40 more weeks (total \~52 weeks) and are denoted as SB204 experienced. Those subjects assigned to vehicle gel in the parent study were rolled over and received open label SB204 in this trial (total \~40 weeks of SB204 treatment) and are denoted SB204 naive.

Participant flow — Overall Study
MilestoneSB204 4% ExperiencedSB204 Naive
Started296305
Completed232216
Not completed6489

Outcome measures

PrimaryNumber 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.

Time frame:
Baseline
Reported as:
Count of participants · Participants
Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)
ParticipantsSB204 ExperiencedSB204 Naive
Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)5962
PrimaryNumber 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.

Time frame:
Week 40/End of Treatment
Reported as:
Count of participants · Participants
Number of Subjects With Treatment Emergent Adverse Events
ParticipantsSB204 ExperiencedSB204 Naive
Number of Subjects With Treatment Emergent Adverse Events5458
SecondaryTolerability 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.

Time frame:
Baseline, Week 4, Week 12, Week 24, Week 36, Week 40
Reported as:
Number · participants
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
participantsSB204 4%
Baseline: Erythema: none (0)493
Baseline: Erythema: mild (1)80
Baseline: Erythema: moderate (2)16
Baseline: Erythema: severe (3)0
Week 4: Erythema: none (0)461
Week 4: Erythema: mild (1)109
Week 4: Erythema: moderate (2)14
Week 4: Erythema: severe (3)0
Week 12: Erythema: none (0)432
Week 12: Erythema: mild (1)84
Week 12: Erythema: moderate (2)10
Week 12: Erythema: severe (3)0
Week 24: Erythema: none (0)411
Week 24: Erythema: mild (1)66
Week 24: Erythema: moderate (2)10
Week 24: Erythema: severe (3)0
Week 36: Erythema: none (0)385
Week 36: Erythema: mild (1)60
Week 36: Erythema: moderate (2)5
Week 36: Erythema: severe (3)0
Week 40: Erythema: none (0)387
Week 40: Erythema: mild (1)57
Week 40: Erythema: moderate (2)4
Week 40: Erythema: severe (3)0
Week 40/ET: Erythema: none (0)419
Week 40/ET Erythema: mild (1)70
Week 40/ET: Erythema: moderate (2)6
Week 40/ET: Erythema: severe (3)0
Baseline: Scaling: none (0)553
Baseline: Scaling: mild (1)33
Baseline: Scaling: moderate (2)3
Baseline: Scaling: severe (3)0
Week 4: Scaling: none (0)535
Week 4: Scaling: mild (1)46
Week 4: Scaling: moderate (2)3
Week 4: Scaling: severe (3)0
Week 12: Scaling: none (0)487
Week 12: Scaling: mild (1)37
Week 12: Scaling: moderate (2)2
Week 12: Scaling: severe (3)0
Week 24: Scaling: none (0)449
Week 24: Scaling: mild (1)35
Week 24: Scaling: moderate (2)3
Week 24: Scaling: severe (3)0
Week 36: Scaling: none (0)398
Week 36: Scaling: mild (1)51
Week 36: Scaling: moderate (2)1
Week 36: Scaling: severe (3)0
Week 40: Scaling: none (0)423
Week 40: Scaling: mild (1)25
Week 40: Scaling: moderate (2)0
Week 40: Scaling: severe (3)0
Week 40/ET: Scaling: none (0)462
Week 40/ET: Scaling: mild (1)32
Week 40/ET: Scaling: moderate (2)1
Week 40/ET: Scaling: severe (3)0
Baseline: Dryness: none (0)510
Baseline: Dryness: mild (1)73
Baseline: Dryness: moderate (2)6
Baseline: Dryness: severe (3)0
Week 4: Dryness: none (0)496
Week 4: Dryness: mild (1)82
Week 4: Dryness: moderate (2)6
Week 4: Dryness: severe (3)0
Week 12: Dryness: none (0)440
Week 12: Dryness: mild (1)82
Week 12: Dryness: moderate (2)4
Week 12: Dryness: severe (3)0
Week 24: Dryness: none (0)398
Week 24: Dryness: mild (1)80
Week 24: Dryness: moderate (1)7
Week 24: Dryness: severe (3)2
Week 36: Dryness: none (0)382
Week 36: Dryness: mild (1)68
Week 36: Dryness: moderate (2)0
Week 36: Dryness: severe (3)0
Week 40: Dryness: none (0)386
Week 40: Dryness: mild (1)61
Week 40: Dryness: moderate (2)1
Week 40: Dryness: severe (3)0
Week 40/ET: Dryness: none (0)422
Week 40/ET Dryness: mild (1)70
Week 40/ET: Dryness: moderate (2)2
Week 40/ET Week 40/ET: Dryness: severe (3)1
Baseline: Pruritus: none (0)560
Baseline: Pruritus: mild (1)26
Baseline: Pruritus: moderate (2)3
Baseline: Pruritus: severe (3) Baseline: Pruritus: severe (3)0
Week 4: Pruritus: none (0)540
Week 4: Pruritus: mild (1)40
Week 4: Pruritus: moderate (2)2
Week 4: Pruritus: severe (3)2
Week 12: Pruritus: none (0)481
Week 12: Pruritus: mild (2)40
Week 12: Pruritus: moderate (2)3
Week 12: Pruritus: severe (3)2
Week 24: Pruritus: none (0)454
Week 24: Pruritus: Week 24 mild (1)30
Week 24: Pruritus: moderate (2)2
Week 24: Pruritus: 24 severe (3)1
Week 36: Pruritus: none (0)429
Week 36: Pruritus: mild (1)18
Week 36: Pruritus: moderate (2)2
Week 36: Pruritus: severe (3)1
Week 40: Pruritus: none (0)418
Week 40: Pruritus: mild (1)29
Week 40: Pruritus: moderate (2)0
Week 40: Pruritus: severe (3)1
Week 40/ET: Pruritus: none (0)457
Week 40/ET: Pruritus: mild (1)34
Week 40/ET: Pruritus: moderate (2)0
Week 40/ET: Pruritus: severe (3)4
Baseline Burning/Stinging: none (0)536
Baseline Burning/Stinging: mild (1)53
Baseline Burning/Stinging: moderate (2)0
Baseline Burning/Stinging: severe (3)0
Week 4: Burning/Stinging: none (0)512
Week 4: Burning/Stinging: mild (1)65
Week 4: Burning/Stinging: moderate (2)7
Week 4: Burning/Stinging: severe (3)0
Week 12: Burning/Stinging: none (0)463
Week 12: Burning/Stinging: mild (1)56
Week 12: Burning/Stinging: moderate (2)7
Week 12: Burning/Stinging: severe (3)0
Week 24: Burning/Stinging: none (0)436
Week 24: Burning/Stinging: mild (1)50
Week 24: Burning/Stinging: moderate (2)1
Week 24: Burning/Stinging: severe (3)0
Week 36: Burning/Stinging: none (0)422
Week 36: Burning/Stinging: mild (1)25
Week 36: Burning/Stinging: moderate (2)3
Week 36: Burning/Stinging: severe (3)0
Week 40: Burning/Stinging: none (0)411
Week 40: Burning/Stinging: mild36
Week 40: Burning/Stinging: moderate (2)1
Week 40: Burning/Stinging: severe (3)0
Week 40/ET: Burning/Stinging: none (0)451
Week 40/ET: Burning/Stinging: mild (1)40
Week 40/ET: Burning/Stinging: moderate (2)2
Week 40/ET: Burning/Stinging: severe (3)2
SecondaryInflammatory Lesion Counts by Study Visit

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

Time frame:
Baseline through Week 40
Reported as:
Mean · number of inflammatory lesions
Inflammatory Lesion Counts by Study Visit
number of inflammatory lesionsSB204 4% ExperiencedSB204 Naive
Baseline13.2 ± 9.9415.3 ± 10.81
Week 412.2 ± 9.9814.3 ± 10.27
Week 1210.8 ± 9.6613.1 ± 9.74
Week 2410.3 ± 7.511.4 ± 9.41
Week 368.3 ± 8.399.7 ± 9.11
Week 407.3 ± 8.138.9 ± 8.99
Week 40/ET7.9 ± 8.479.8 ± 9.46
SecondaryNon-Inflammatory Lesion Counts by Study Visit

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

Time frame:
Baseline through Week 40
Reported as:
Mean · number of non-inflammatory lesions
Non-Inflammatory Lesion Counts by Study Visit
number of non-inflammatory lesionsSB204 4% ExperiencedSB204 Naive
Baseline23.6 ± 16.0825.5 ± 18.32
Week 421.9 ± 16.2723.0 ± 16.07
Week 1219.7 ± 15.1421.5 ± 16.09
Week 2417.2 ± 14.6717.5 ± 13.20
Week 3614.0 ± 13.1915.4 ± 13.06
Week 4012.6 ± 13.7714.1 ± 12.59
Week 40/ET13.7 ± 14.6415.4 ± 14.70

Adverse events

Collected over Baseline through Week 40 (approximately 9 months). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SB204 Experienced0/296 (0%)4/296 (1.4%)34/296 (11.5%)
SB204 Naive0/305 (0%)2/305 (0.7%)32/305 (10.5%)
Most frequent serious events
Most frequent serious events
EventSB204 ExperiencedSB204 Naive
AppendicitisInfections and infestations1/2960/305
AnxietyPsychiatric disorders1/2960/305
Conduct DisorderPsychiatric disorders1/2960/305
Gastrointestinal HaemorrhageGastrointestinal disorders1/2960/305
SepsisInfections and infestations0/2961/305
Back PainMusculoskeletal and connective tissue disorders0/2961/305
Most frequent other events
Most frequent other events
EventSB204 ExperiencedSB204 Naive
NasopharyngitisInfections and infestations5/29614/305
Application site drynessGeneral disorders8/2963/305
HeadacheNervous system disorders7/2961/305
Application site pruritusGeneral disorders3/2966/305
InfluenzaInfections and infestations4/2963/305
Upper respiratory tract infectionInfections and infestations4/2962/305
Application site painGeneral disorders3/2964/305

Baseline characteristics

Safety population. As this was an open label, long term safety study, all subjects were in the safety population.

Age, Continuous
Age, Continuous(years)SB204 ExperiencedSB204 NaiveTotal
Mean21.4 ± 8.8621.0 ± 8.6621.2 ± 8.76
Age, Customized
Age, Customized(Participants)SB204 ExperiencedSB204 NaiveTotal
Juvenile (<18 years)133149282
Adult (≥18 years)163156319
Sex: Female, Male
Sex: Female, Male(Participants)SB204 ExperiencedSB204 NaiveTotal
Female174183357
Male122122244
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SB204 ExperiencedSB204 NaiveTotal
Hispanic or Latino111122233
Not Hispanic or Latino185183368
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SB204 ExperiencedSB204 NaiveTotal
American Indian or Alaska Native231942
Asian123
Native Hawaiian or Other Pacific Islander112
Black or African American5856114
White211221432
More than one race268
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)SB204 ExperiencedSB204 NaiveTotal
United States296305601
Parent study (NI-AC301 or NI-AC302)
Parent study (NI-AC301 or NI-AC302)(Participants)SB204 ExperiencedSB204 NaiveTotal
NI-AC301150159309
NI-AC302146146292
08

Study locations

69 sites
  • 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 #176
    Saint Petersburg, Florida 33716, United States
  • CIL #227
    Sanford, Florida 32771, United States
  • CIL #211
    South Miami, Florida 33413, 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
    Saint 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
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02798120
Lead sponsor
Novan, Inc.
Collaborators
Chiltern International Inc.
Responsible party
Sponsor
First posted
Jun 14, 2016
Start date
May 12, 2016
Primary completion
Apr 2017
Completion
Apr 27, 2017
Results posted
May 12, 2023
Last update
May 12, 2023

Study contacts

Joyce Rico
study chair · Novan, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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