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).
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 1,330 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →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.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SB204 4% topically once daily
Drug: SB204 4%
Vehicle Gel topically once daily
Drug: Vehicle Gel
Applied topically once daily
Also known as: NVN1000
Applied topically one daily
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: 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 Count
Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis)
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
| Milestone | SB204 4% | Vehicle Gel |
|---|---|---|
| Started | 664 | 666 |
| Completed | 576 | 574 |
| Not completed | 88 | 92 |
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 | -13.1 ± 10.27 | -10.9 ± 10.81 |
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 | -15.3 ± 14.30 | -12.7 ± 16.01 |
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 | 120 | 89 |
The percent change from baseline in inflammatory lesion count
| Percentage change from baseline | SB204 4% | Vehicle Gel |
|---|---|---|
| Percent Change in Inflammatory Lesion Count | -48.5 ± 36.36 | -39.2 ± 38.20 |
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 | -40.5 ± 36.35 | -33.1 ± 39.59 |
Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis)
| Days | SB204 4% | Vehicle Gel |
|---|---|---|
| Time to Reduction in Inflammatory Lesion Count | 38.0 (31.0 to 56.0) | 56.0 (35.0 to 57.0) |
Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis)
| Days | SB204 4% | Vehicle Gel |
|---|---|---|
| 25% Quartile | 85.0 (85.0 to 86.0) | 87.0 (86.0 to 91.0) |
| 50% Quartile (Median) | 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.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SB204 4% | 0/666 (0%) | 1/666 (0.2%) | 49/666 (7.4%) |
| Vehicle Gel | 0/661 (0%) | 3/661 (0.5%) | 25/661 (3.8%) |
| Event | SB204 4% | Vehicle Gel |
|---|---|---|
| CellulitisInfections and infestations | 0/666 | 1/661 |
| EpilepsyNervous system disorders | 0/666 | 1/661 |
| HydrocephalusNervous system disorders | 0/666 | 1/661 |
| Intracranial aneurysmNervous system disorders | 0/666 | 1/661 |
| Subarachnoid haemorhageNervous system disorders | 0/666 | 1/661 |
| Brain neoplasm benignNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/666 | 0/661 |
| Event | SB204 4% | Vehicle Gel |
|---|---|---|
| NasopharyngitisInfections and infestations | 15/666 | 18/661 |
| Application site painGeneral disorders | 14/666 | 4/661 |
| Application site erythemaGeneral disorders | 10/666 | 2/661 |
| HeadacheNervous system disorders | 10/666 | 1/661 |
Intent to treat population (ITT): All subjects who were randomized and dispensed study medication, grouped according to the treatment group to which they were assigned at the time of randomization. A total of 1330 subjects were randomized but 3 were withdrawn after randomization and prior to being dispensed study medication (1 subject in the SB204 group and 2 in the Vehicle group).
| Age, Continuous(years) | SB204 4% | Vehicle Gel | Total |
|---|---|---|---|
| Mean | 21.4 ± 8.52 | 21.8 ± 8.77 | 21.6 ± 8.65 |
| Sex: Female, Male(Participants) | SB204 4% | Vehicle Gel | Total |
|---|---|---|---|
| Female | 411 | 398 | 809 |
| Male | 252 | 266 | 518 |
| Ethnicity (NIH/OMB)(Participants) | SB204 4% | Vehicle Gel | Total |
|---|---|---|---|
| Hispanic or Latino | 202 | 209 | 411 |
| Not Hispanic or Latino | 461 | 455 | 916 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SB204 4% | Vehicle Gel | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 3 | 4 |
| Asian | 43 | 45 | 88 |
| Native Hawaiian or Other Pacific Islander | 1 | 3 | 4 |
| Black or African American | 158 | 147 | 305 |
| White | 449 | 457 | 906 |
| More than one race | 11 | 9 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | SB204 4% | Vehicle Gel | Total |
|---|---|---|---|
| United States | 663 | 664 | 1327 |
| 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 | 599 | 587 | 1186 |
| 4--severe | 64 | 77 | 141 |
PDFs hosted by the registry, ClinicalTrials.gov.
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