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| Name | Class |
|---|---|
| Chiltern International Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB204 4% | Experimental | SB204 4% topically once daily |
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| Vehicle Gel | Placebo Comparator | Vehicle Gel topically once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB204 4% | Drug | Once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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.
| Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Inflammatory Lesion Count | The percent change from baseline in inflammatory lesion count | Baseline and Week 12 |
| Percent Change in Non-inflammatory Lesion Count | The percent change from baseline in non-inflammatory lesion count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joyce Rico, MD | Novan, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIL #146 | Anaheim | California | 92801 | United States | ||
| CIL #118 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | SB204 4% | SB204 4% topically once daily |
| FG001 | Vehicle Gel | Vehicle Gel (placebo comparator) topically once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2016 | Mar 2, 2023 |
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| Vehicle Gel |
| Drug |
Placebo comparator |
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| Baseline and Week 12 |
| Time to Reduction in Inflammatory Lesion Counts | Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier) | Week 12 |
| Time to Improvement in IGA | Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis). | Week 12 |
| Encinitas |
| California |
| 92024 |
| United States |
| CIL #186 | Fresno | California | 93720 | United States |
| CIL #210 | Fresno | California | 93720 | United States |
| CIL #209 | Oceanside | California | 92056 | United States |
| CIL #161 | San Diego | California | 92103 | United States |
| CIL #113 | San Diego | California | 92123 | United States |
| CIL #199 | Santa Rosa | California | 95405 | United States |
| CIL #103 | Boca Raton | Florida | 33486 | United States |
| CIL #173 | Hialeah | Florida | 33012 | United States |
| CIL #212 | Homestead | Florida | 33030 | United States |
| CIL #222 | Lauderdale Lakes | Florida | 33406 | United States |
| CIL #157 | Miami | Florida | 33144 | United States |
| CIL #177 | North Miami Beach | Florida | 33162 | United States |
| CIL #150 | Orlando | Florida | 32801 | United States |
| CIL #172 | Orlando | Florida | 32814 | United States |
| CIL #203 | Ormond Beach | Florida | 32174 | United States |
| CIL #211 | South Miami | Florida | 33413 | United States |
| CIL #229 | Tampa | Florida | 33609 | United States |
| CIL #153 | Wellington | Florida | 33414 | United States |
| Cil # 179 | Chicago | Illinois | 60611 | United States |
| CIL #215 | Wichita | Kansas | 67207 | United States |
| CIL #117 | Louisville | Kentucky | 40202 | United States |
| CIL #180 | New Orleans | Louisiana | 70112 | United States |
| CIL #205 | Glenn Dale | Maryland | 20769 | United States |
| CIL #230 | Quincy | Massachusetts | 02169 | United States |
| CIL #112 | Detroit | Michigan | 48183 | United States |
| CIL #149 | Troy | Michigan | 48084 | United States |
| CIL #225 | Saint Joseph | Missouri | 64506 | United States |
| CIL #187 | St Louis | Missouri | 63141 | 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 #107 | New York | New York | 10155 | United States |
| CIL #108 | Rochester | New York | 14623 | United States |
| CIL #104 | Stony Brook | New York | 11790 | United States |
| CIL #193 | High Point | North Carolina | 27262 | United States |
| CIL #166 | Winston-Salem | North Carolina | 27103 | United States |
| CIL #226 | Cincinnati | Ohio | 45255 | United States |
| CIL #200 | Portland | Oregon | 97210 | United States |
| CIL #236 | Charleston | South Carolina | 29414 | United States |
| CIL #217 | Chattanooga | Tennessee | 37421 | United States |
| CIL #198 | Arlington | Texas | 76011 | United States |
| CIL #154 | Beaumont | Texas | 77701 | United States |
| CIL #162 | Carrollton | Texas | 75010 | 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 #171 | San Antonio | Texas | 78229 | United States |
| CIL #164 | Sugar Land | Texas | 77479 | United States |
| CIL #106 | Salt Lake City | Utah | 84117 | United States |
| CIL #114 | Norfolk | Virginia | 23502 | United States |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | SB204 4% | SB204 4% topically once daily |
| BG001 | Vehicle Gel | Vehicle Gel (placebo comparator) topically once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria. | Count of Participants | Participants |
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| Race (NIH/OMB) | One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Baseline Investigator Global Assessment | Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent To Treat population (ITT) | Posted | Mean | Standard Deviation | inflammatory acne lesions | Baseline and Week 12 |
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| Primary | 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). | Intent to Treat population (ITT) | Posted | Mean | Standard Deviation | non-inflammatory acne lesions | Baseline and Week 12 |
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| Primary | 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.
| ITT population; subjects who had a Week 12 (study completion) visit. | Posted | Count of Participants | Participants | Baseline and Week 12 |
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| Secondary | Percent Change in Inflammatory Lesion Count | The percent change from baseline in inflammatory lesion count | ITT population. | Posted | Mean | Standard Deviation | Percentage change from baseline | Baseline and Week 12 |
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| Secondary | Percent Change in Non-inflammatory Lesion Count | The percent change from baseline in non-inflammatory lesion count | ITT population | Posted | Mean | Standard Deviation | Percentage change from baseline | Baseline and Week 12 |
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| Secondary | Time to Reduction in Inflammatory Lesion Counts | Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier) | ITT population; overall number of participants analyzed = the # of participants who achieved at least a 35% reduction in their inflammatory lesion counts. | Posted | Median | 95% Confidence Interval | Days | Week 12 |
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| Secondary | Time to Improvement in IGA | Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis). | ITT population. Overall number of participants analyzed = number of participants who achieved a 2 or more grade improvement in their IGA score. This was a Kaplan-Meier analysis; for both the SB204 4% and Vehicle Gel treatment groups, the median was not estimable due to < 50% of subjects achieving a 2 or more grade improvement in their IGA score. | Posted | Number | 95% Confidence Interval | Days | Week 12 |
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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.
Adverse events were collected for all subjects who were randomized and received at least one dose of study medication. Two subjects who were randomized to the Vehicle group received SB204 and per the definition of the Safety Population in the Statistical Analysis Plan, these subjects were analyzed in the SB204 group. Therefore, 654 subjects were in the SB204 group and 652 subjects were in the Vehicle group for analyses of all cause mortality, adverse events and serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SB204 4% | SB204 4% topically once daily | 0 | 654 | 0 | 654 | 66 | 654 |
| EG001 | Vehicle Gel | Vehicle Gel (placebo comparator) topically once daily | 1 | 652 | 4 | 652 | 10 | 652 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 18.1 | Systematic Assessment | Subject was a 66 year old male; died of natural causes (unknown) and the event was considered to be not related to treatment |
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| Seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Bulimia nervosa | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Application site dryness | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cathy White, Vice President, Drug Development Operations | Novan, Inc. | 919-485-8080 | clinical@novan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2017 | Mar 2, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
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| C000709171 | berdazimer sodium |
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| 1--almost clear |
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| 2--mild |
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| 3--moderate |
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| 4--severe |
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