A Phase 3 interventional study of SB204 4% and Vehicle Gel in Acne Vulgaris, sponsored by Novan, Inc.. Completed at 55 sites in United States. Open to participants aged 9 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by Novan, Inc. · Phase 3, Interventional, and Treatment
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.
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).
Exclusion Criteria:
SB204 4% topically once daily
Drug: SB204 4%
Vehicle Gel topically once daily
Drug: Vehicle Gel
Once daily
Also known as: NVN1000
Placebo comparator
Also known as: Placebo
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.
Time frame: 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).
Time frame: 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. 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
Time frame: Baseline and Week 12
Percent Change in Inflammatory Lesion Count
The percent change from baseline in inflammatory lesion count
Time frame: Baseline and Week 12
Percent Change in Non-inflammatory Lesion Count
The percent change from baseline in non-inflammatory lesion count
Time frame: Baseline and Week 12
Time to Reduction in Inflammatory Lesion Counts
Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier)
Time frame: Week 12
Time to Improvement in IGA
Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis).
Time frame: Week 12
1300 participants were planned to be recruited from dermatologists and other (e. g. family physicians, research clinics). A total of 1307 participants were randomized. Enrollment began on 22Feb2016 and the last subject completed on 21Dec2016. There were 1306 participants in the intent to treat (ITT) and safety populations.
| Milestone | SB204 4% | Vehicle Gel |
|---|---|---|
| Started | 653 | 654 |
| Completed | 571 | 577 |
| Not completed | 82 | 77 |
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.
| inflammatory acne lesions | SB204 4% | Vehicle Gel |
|---|---|---|
| Absolute Change From Baseline in Inflammatory Lesion Counts | -12.4 ± 10.30 | -11.3 ± 10.46 |
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).
| non-inflammatory acne lesions | SB204 4% | Vehicle Gel |
|---|---|---|
| Absolute Change From Baseline in Non-inflammatory Lesion Counts | -16.0 ± 16.36 | -13.5 ± 16.97 |
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
| Participants | SB204 4% | Vehicle Gel |
|---|---|---|
| Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12 | 83 | 84 |
The percent change from baseline in inflammatory lesion count
| Percentage change from baseline | SB204 4% | Vehicle Gel |
|---|---|---|
| Percent Change in Inflammatory Lesion Count | -45.9 ± 36.65 | -43.1 ± 38.68 |
The percent change from baseline in non-inflammatory lesion count
| Percentage change from baseline | SB204 4% | Vehicle Gel |
|---|---|---|
| Percent Change in Non-inflammatory Lesion Count | -39.6 ± 35.84 | -34.6 ± 41.82 |
Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier)
| Days | SB204 4% | Vehicle Gel |
|---|---|---|
| Time to Reduction in Inflammatory Lesion Counts | 31.0 (30.0 to 37.0) | 31.0 (29.0 to 55.0) |
Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis).
| Days | SB204 4% | Vehicle Gel |
|---|---|---|
| 25% Quartile | 87.0 (86.0 to 90.0) | 87.0 (86.0 to NA) |
| 50% Quartile | NA (NA to NA) | NA (NA to NA) |
| 75% Quartile | NA (NA to NA) | NA (NA to NA) |
Collected over Adverse events were collected after the subject signed the informed consent and completed any study assessment until the end of the final study visit, approximately 12 weeks for most subjects.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SB204 4% | 0/654 (0%) | 0/654 (0%) | 66/654 (10.1%) |
| Vehicle Gel | 1/652 (0.2%) | 4/652 (0.6%) | 10/652 (1.5%) |
| Event | SB204 4% | Vehicle Gel |
|---|---|---|
| Impaired gastric emptyingGastrointestinal disorders | 0/654 | 1/652 |
| DeathGeneral disorders | 0/654 | 1/652 |
| SeizureNervous system disorders | 0/654 | 1/652 |
| Bulimia nervosaPsychiatric disorders | 0/654 | 1/652 |
| EndometriosisReproductive system and breast disorders | 0/654 | 1/652 |
| Event | SB204 4% | Vehicle Gel |
|---|---|---|
| Application site painGeneral disorders | 21/654 | 3/652 |
| Application site pruritusGeneral disorders | 16/654 | 3/652 |
| NasopharyngitisInfections and infestations | 11/654 | 10/652 |
| Application site erythemaGeneral disorders | 11/654 | 1/652 |
| Application site drynessGeneral disorders | 7/654 | 2/652 |
Intent to treat (ITT) population: all study subjects who were randomized and dispensed study medication, and were grouped by the treatment the subject was assigned to at the time of randomization. There were 653 subjects randomized to SB204, but one subject was excluded from the ITT due to not meeting inclusion/exclusion criteria, thereby reducing the Baseline ITT population for SB204 to 652. All efficacy analyses were performed on the ITT population.
| Age, Continuous(years) | SB204 4% | Vehicle Gel | Total |
|---|---|---|---|
| Mean | 21.1 ± 8.25 | 21.3 ± 8.38 | 21.2 ± 8.32 |
| Sex: Female, Male(Participants) | SB204 4% | Vehicle Gel | Total |
|---|---|---|---|
| Female | 400 | 406 | 806 |
| Male | 252 | 248 | 500 |
| Race (NIH/OMB)(Participants) | SB204 4% | Vehicle Gel | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 2 | 5 |
| Asian | 28 | 26 | 54 |
| Native Hawaiian or Other Pacific Islander | 2 | 2 | 4 |
| Black or African American | 143 | 148 | 291 |
| White | 456 | 455 | 911 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 20 | 21 | 41 |
| Region of Enrollment(Participants) | SB204 4% | Vehicle Gel | Total |
|---|---|---|---|
| United States | 652 | 654 | 1306 |
| Baseline Investigator Global Assessment(Participants) | SB204 4% | Vehicle Gel | Total |
|---|---|---|---|
| 0--clear | 0 | 0 | 0 |
| 1--almost clear | 0 | 0 | 0 |
| 2--mild | 0 | 0 | 0 |
| 3--moderate | 557 | 575 | 1132 |
| 4--severe | 94 | 78 | 172 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novan, Inc.