Acne VulgarisPhase 3NCT02798120
P3 Long Term Safety Study of Once Daily SB204 in Acne
A Phase 3 study testing SB204 4% in people with Acne Vulgaris, run by Novan, Inc. at 69 sites in United States.
Trial summary
This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris. Read more about this study
- Who is it for?
- Ages 9 to 99 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- SB204 4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 69 sitesUnited States
- Study dates
- 12 May 2016to 27 Apr 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have completed 12 weeks of treatment in NI-AC301 or NI-AC302
Who cannot join
- 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.
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
CIL #156
Albuquerque, New Mexico, 87102
CIL #146
Anaheim, California, 92801
CIL #198
Arlington, Texas, 76011
CIL #160
Austin, Texas, 78735
CIL #154
Beaumont, Texas, 77701
CIL #201
Berlin, New Jersey, 08009
CIL #138
Birmingham, Alabama, 35202
CIL #103
Boca Raton, Florida, 33486
CIL #137
Broomall, Pennsylvania, 19008
CIL #184
Bryan, Texas, 77802
CIL #139
Cerritos, California, 90703
CIL #217
Chattanooga, Tennessee, 37421
CIL #216
Chula Vista, California, 91911
CIL #169
Cincinnati, Ohio, 45246
CIL #226
Cincinnati, Ohio, 45255
CIL #186
Fresno, California, 93720
CIL #210
Fresno, California, 93720
CIL #237
Gresham, Oregon, 97030
CIL #208
Hialeah, Florida, 33012
CIL #212
Homestead, Florida, 33030
CIL #188
Houston, Texas, 77055
CIL #174
Huntington Beach, California, 92647
CIL #213
La Mesa, California, 91942
CIL #182
Las Vegas, Nevada, 89129
CIL #222
Lauderdale Lakes, Florida, 33406
CIL #117
Louisville, Kentucky, 40202
CIL #105
Lynchburg, Virginia, 24501
CIL #170
Miami Lakes, Florida, 33016
CIL #204
Miami Springs, Florida, 33166
CIL #218
Mobile, Alabama, 36608
CIL #219
Monroe, Louisiana, 71203
CIL #141
Montclair, New Jersey, 07042
CIL #175
New Albany, Indiana, 47150
CIL #116
Newnan, Georgia, 30263
CIL #148
Norfolk, Nebraska, 68701
CIL #231
Norfolk, Virginia, 23507
CIL #209
Oceanside, California, 92056
CIL #140
Omaha, Nebraska, 68134
CIL #172
Orlando, Florida, 32814
CIL #185
Ormond Beach, Florida, 32174
CIL #203
Ormond Beach, Florida, 32174
CIL #191
Overland Park, Kansas, 66215
CIL #178
Philadelphia, Pennsylvania, 19103
CIL #189
Phoenix, Arizona, 85018
CIL #110
Pinellas Park, Florida, 33781
CIL #151
Plano, Texas, 75093
CIL #168
Plano, Texas, 75234
CIL #200
Portland, Oregon, 97210
CIL #194
Richmond, Kentucky, 40475
CIL #108
Rochester, New York, 14623
CIL #190
Sacramento, California, 95821
CIL #221
Salisbury, North Carolina, 28144
CIL #106
Salt Lake City, Utah, 84117
CIL #224
San Antonio, Texas, 78218
CIL #161
San Diego, California, 92103
CIL #113
San Diego, California, 92123
CIL #227
Sanford, Florida, 32771
CIL #195
Santa Ana, California, 92705
CIL #119
Santa Monica, California, 90404
CIL #199
Santa Rosa, California, 95405
CIL #143
Savannah, Georgia, 31406
CIL #211
South Miami, Florida, 33413
CIL #187
St Louis, Missouri, 63141
CIL #176
St. Petersburg, Florida, 33716
CIL #152
Tampa, Florida, 33607
CIL #229
Tampa, Florida, 33609
CIL #144
Tampa, Florida, 33634
CIL #153
Wellington, Florida, 33414
CIL #215
Wichita, Kansas, 67207
About this study
Official title: 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.
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.
- Conditions
- Acne Vulgaris
- Being tested
- SB204 4%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB204 4%Drug
Also called NVN1000
Open label, topical SB204 4%
| Study group | Role | What they receive |
|---|---|---|
| SB204 4% | Experimental | 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. Receives: Drug: SB204 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 40/End of Treatment
Secondary outcomes (3)
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.
Measured: 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
Measured: Baseline through Week 40
Non-Inflammatory Lesion Counts by Study Visit
Absolute count of non-inflammatory lesions by study visit (face only)
Measured: Baseline through Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start12 May 2016
- Primary completionApr 2017
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Responsible party
- Sponsor
- Investigators
- Joyce Rico, Study chair, Novan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798120
- Sponsor's protocol ID
- NI-AC303
- Status last verified
- May 2023
- First submitted
- 9 Jun 2016
- Last updated
- 12 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02798120
- Acronym / sponsor ID
- NI-AC303
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Study start
- 12 May 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Posted 12 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB204 4% | Experimental | Drug: 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. |
Who may qualify
- Ages
- 9 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Have completed 12 weeks of treatment in NI-AC301 or NI-AC302
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB204 4%Also: NVN1000Open label, topical SB204 4% | Drug | SB204 4% |
Primary outcome
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.
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.
3 secondary outcomes
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
Inflammatory Lesion Counts by Study Visit
Time frame: Baseline through Week 40
Non-Inflammatory Lesion Counts by Study Visit
Time frame: Baseline through Week 40
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Rico study chair
Novan, Inc.
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SB204 4% in people with Acne Vulgaris, run by Novan, Inc. at 69 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.