Acne VulgarisPhase 3NCT02672332
P3 Study in Acne Comparing Once Daily SB204 and Vehicle
A Phase 3 study testing SB204 4% in people with Acne Vulgaris, run by Novan, Inc. at 55 sites in United States.
Trial summary
This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US. 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?
- Yes, some participants may receive a placebo
- How many people
- 1,307 participants
- Where
- 55 sitesUnited States
- Study dates
- 22 Feb 2016to 21 Dec 2016
- 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
- Moderate to severe acne
- Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face
- Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)
Who cannot join
- Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant
- Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
United States55 sites
CIL #156
Albuquerque, New Mexico, 87102
CIL #146
Anaheim, California, 92801
CIL #198
Arlington, Texas, 76011
CIL #154
Beaumont, Texas, 77701
CIL #201
Berlin, New Jersey, 08009
CIL #103
Boca Raton, Florida, 33486
CIL #162
Carrollton, Texas, 75010
CIL #236
Charleston, South Carolina, 29414
CIL #217
Chattanooga, Tennessee, 37421
Cil # 179
Chicago, Illinois, 60611
CIL #226
Cincinnati, Ohio, 45255
CIL #112
Detroit, Michigan, 48183
CIL #118
Encinitas, California, 92024
CIL #186
Fresno, California, 93720
CIL #210
Fresno, California, 93720
CIL #205
Glenn Dale, Maryland, 20769
CIL #173
Hialeah, Florida, 33012
CIL #193
High Point, North Carolina, 27262
CIL #212
Homestead, Florida, 33030
CIL #188
Houston, Texas, 77055
CIL #182
Las Vegas, Nevada, 89129
CIL #222
Lauderdale Lakes, Florida, 33406
CIL #117
Louisville, Kentucky, 40202
CIL #157
Miami, Florida, 33144
CIL #141
Montclair, New Jersey, 07042
CIL #180
New Orleans, Louisiana, 70112
CIL #107
New York, New York, 10155
CIL #114
Norfolk, Virginia, 23502
CIL #177
North Miami Beach, Florida, 33162
CIL #209
Oceanside, California, 92056
CIL #140
Omaha, Nebraska, 68134
CIL #150
Orlando, Florida, 32801
CIL #172
Orlando, Florida, 32814
CIL #203
Ormond Beach, Florida, 32174
CIL #151
Plano, Texas, 75093
CIL #168
Plano, Texas, 75234
CIL #200
Portland, Oregon, 97210
CIL #230
Quincy, Massachusetts, 02169
CIL #108
Rochester, New York, 14623
CIL #225
Saint Joseph, Missouri, 64506
CIL #106
Salt Lake City, Utah, 84117
CIL #224
San Antonio, Texas, 78218
CIL #171
San Antonio, Texas, 78229
CIL #161
San Diego, California, 92103
CIL #113
San Diego, California, 92123
CIL #199
Santa Rosa, California, 95405
CIL #211
South Miami, Florida, 33413
CIL #187
St Louis, Missouri, 63141
CIL #104
Stony Brook, New York, 11790
CIL #164
Sugar Land, Texas, 77479
CIL #229
Tampa, Florida, 33609
CIL #149
Troy, Michigan, 48084
CIL #153
Wellington, Florida, 33414
CIL #215
Wichita, Kansas, 67207
CIL #166
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris
This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
Read the detailed description
This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).
- Conditions
- Acne Vulgaris
- Being tested
- SB204 4%, Vehicle Gel
- 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
Once daily
Vehicle GelDrug
Also called Placebo
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| SB204 4% | Experimental | SB204 4% topically once daily Receives: Drug: SB204 4% |
| Vehicle Gel | Placebo comparator | Vehicle Gel topically once daily Receives: Drug: Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Inflammatory Lesion Counts
The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.
Measured: Baseline and Week 12
Absolute Change From Baseline in Non-inflammatory Lesion Counts
The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).
Measured: Baseline and Week 12
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12
Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows:
Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions.
- Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red).
- Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions.
- Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion.
- Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions
Measured: Baseline and Week 12
Secondary outcomes (4)
Percent Change in Inflammatory Lesion Count
The percent change from baseline in inflammatory lesion count
Measured: Baseline and Week 12
Percent Change in Non-inflammatory Lesion Count
The percent change from baseline in non-inflammatory lesion count
Measured: Baseline and Week 12
Time to Reduction in Inflammatory Lesion Counts
Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier)
Measured: Week 12
Time to Improvement in IGA
Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start22 Feb 2016
- Primary completionDec 2016
- Study completion21 Dec 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,307 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, MD, Study chair, Novan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672332
- Sponsor's protocol ID
- NI-AC301
- Status last verified
- Apr 2023
- First submitted
- 1 Feb 2016
- Last updated
- 24 Jul 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 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02672332
- Acronym / sponsor ID
- NI-AC301
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,307 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Posted 6 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 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
Detailed description
This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB204 4% | Experimental | Drug: SB204 4%SB204 4% topically once daily |
| Vehicle Gel | Placebo comparator | Drug: Vehicle GelVehicle Gel topically once daily |
Who may qualify
- Ages
- 9 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe acne
- Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face
- Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)
Key exclusion criteria (2 listed)
- Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant
- Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic 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: NVN1000Once daily | Drug | SB204 4% |
| Vehicle GelAlso: PlaceboPlacebo comparator | Drug | Vehicle Gel |
Primary outcome
Absolute Change From Baseline in Inflammatory Lesion Counts
Time frame: Baseline and Week 12
The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.
Absolute Change From Baseline in Non-inflammatory Lesion Counts
Time frame: Baseline and Week 12
The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12
Time frame: Baseline and Week 12
Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows: Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions. 1. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red). 2. Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions. 3. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion. 4. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions
4 secondary outcomes
Percent Change in Inflammatory Lesion Count
Time frame: Baseline and Week 12
Percent Change in Non-inflammatory Lesion Count
Time frame: Baseline and Week 12
Time to Reduction in Inflammatory Lesion Counts
Time frame: Week 12
Time to Improvement in IGA
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 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, MD study chair
Novan, Inc.
55 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 55 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 3 inclusion and 2 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 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. Some participants in this study may receive a placebo. 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 6 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?
Absolute Change From Baseline in Inflammatory Lesion Counts (time frame: Baseline and Week 12). The study lists 3 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 24 Jul 2023.