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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 | Applied topically 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.
| 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 #214 | Birmingham | Alabama | 35233 | United States | ||
| CIL #218 |
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| ID | Title | Description |
|---|---|---|
| FG000 | SB204 4% | SB204 4%: Applied topically once daily |
| FG001 | Vehicle Gel | Vehicle Gel: Applied 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 8, 2023 |
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| Vehicle Gel | Drug | Applied topically one daily |
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| 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) | Week 12 |
| Time to Improvement in IGA | Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis) | Week 12 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| CIL #189 | Phoenix | Arizona | 85018 | United States |
| CIL #139 | Cerritos | California | 90703 | United States |
| CIL #216 | Chula Vista | California | 91911 | United States |
| CIL #181 | Encino | California | 91436 | United States |
| CIL #174 | Huntington Beach | California | 92647 | United States |
| CIL #213 | La Mesa | California | 91942 | United States |
| CIL #190 | Sacramento | California | 95821 | United States |
| CIL #111 | San Diego | California | 92123 | United States |
| CIL #195 | Santa Ana | California | 92705 | United States |
| CIL #119 | Santa Monica | California | 90404 | United States |
| CIL #158 | Bradenton | Florida | 34201 | United States |
| CIL #208 | Hialeah | Florida | 33012 | United States |
| CIL #142 | Miami | Florida | 33157 | United States |
| CIL #170 | Miami Lakes | Florida | 33016 | United States |
| CIL #204 | Miami Springs | Florida | 33166 | United States |
| CIL #185 | Ormond Beach | Florida | 32174 | United States |
| CIL #110 | Pinellas Park | Florida | 33781 | United States |
| CIL #227 | Sanford | Florida | 32771 | United States |
| CIL #176 | St. Petersburg | Florida | 33716 | United States |
| CIL #152 | Tampa | Florida | 33607 | United States |
| CIL #144 | Tampa | Florida | 33634 | United States |
| CIL #116 | Newnan | Georgia | 30263 | United States |
| CIL #143 | Savannah | Georgia | 31406 | United States |
| CIL #175 | New Albany | Indiana | 47150 | United States |
| CIL #191 | Overland Park | Kansas | 66215 | United States |
| CIL #228 | Louisville | Kentucky | 40217 | United States |
| CIL #194 | Richmond | Kentucky | 40475 | United States |
| CIL #219 | Monroe | Louisiana | 71203 | United States |
| CIL #145 | Boston | Massachusetts | 02114 | United States |
| CIL #155 | Bay City | Michigan | 48706 | United States |
| CIL #220 | St Louis | Missouri | 63141 | United States |
| CIL #148 | Norfolk | Nebraska | 68701 | United States |
| CIL #206 | Omaha | Nebraska | 68144 | United States |
| CIL #202 | Morristown | New Jersey | 07962 | United States |
| CIL #197 | New York | New York | 10024 | United States |
| CIL #196 | Charlotte | North Carolina | 28277 | United States |
| CIL #192 | Raleigh | North Carolina | 27612 | United States |
| CIL #221 | Salisbury | North Carolina | 28144 | United States |
| CIL #169 | Cincinnati | Ohio | 45246 | United States |
| CIL #237 | Gresham | Oregon | 97030 | United States |
| CIL #137 | Broomall | Pennsylvania | 19008 | United States |
| CIL #147 | Hershey | Pennsylvania | 17033 | United States |
| CIL #178 | Philadelphia | Pennsylvania | 19103 | United States |
| CIL #160 | Austin | Texas | 78735 | United States |
| CIL #183 | Austin | Texas | 78759 | United States |
| CIL #184 | Bryan | Texas | 77802 | United States |
| CIL #163 | Channelview | Texas | 77530 | United States |
| CIL #165 | Dallas | Texas | 75230 | United States |
| CIL #167 | Houston | Texas | 77030 | United States |
| CIL #223 | Plano | Texas | 75024 | United States |
| CIL #159 | San Antonio | Texas | 78229 | United States |
| CIL #105 | Lynchburg | Virginia | 24501 | United States |
| CIL #231 | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
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| NOT COMPLETED |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | SB204 4% | SB204 4%: Applied topically once daily |
| BG001 | Vehicle Gel | Vehicle Gel: Applied topically once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Baseline Investigator Global Assessment | 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 (ITT) population | 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 (ITT) population | 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.
| Intent to treat (ITT) population; subjects who had Week 12 (study completion) visits. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Percent Change in Inflammatory Lesion Count | The percent change from baseline in inflammatory lesion count | Intent to treat (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 | Intent to treat (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 Count | Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis) | Intent to treat (ITT) population | 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) | Intent to treat (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.
Adverse events were collected for all subjects who were randomized and received at least one dose of study medication. Three 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, 666 subjects were in the SB204 group and 661 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%: Applied topically once daily | 0 | 666 | 1 | 666 | 49 | 666 |
| EG001 | Vehicle Gel | Vehicle Gel: Applied topically once daily | 0 | 661 | 3 | 661 | 25 | 661 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brain neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Intracranial aneurysm | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Subarachnoid haemorhage | Nervous system 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 erythema | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Headache | Nervous system 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 | Dec 22, 2016 | Mar 8, 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 |
|---|---|
| C000709171 | berdazimer sodium |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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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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