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| Name | Class |
|---|---|
| Chiltern International Inc. | INDUSTRY |
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This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.
A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB204 4% | Experimental | All subjects received SB204 4% once daily (QD) in this open label study. Subjects assigned to SB204 4% QD in the parent study (NI-AC301/302) continued to receive SB204 for 40 more weeks. Subjects assigned to Vehicle Gel in the parent study (NI-AC301/302) received SB204 4% QD in this open label study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB204 4% | Drug | Open label, topical SB204 4% |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303) | This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive. | Baseline |
| Number of Subjects With Treatment Emergent Adverse Events | Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303. | Week 40/End of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Analysis of cutaneous tolerability scores at each visit through end of treatment. Baseline is the Week 12 assessment from the previous study (NI-AC301 or NI-AC302). The Cutaneous Tolerability Assessment scale consisted of the investigator's assessment of erythema, scaling, and dryness at the time the assessment was made. Pruritus and burning/stinging were based on the subject's report for the previous 24 hours. Each component was graded on a scale of 0-3, with 0 being none (not present) and 3 being severe. Higher scores indicated a higher severity of reaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joyce Rico | Novan, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIL #138 | Birmingham | Alabama | 35202 | United States | ||
| CIL #218 |
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Subjects who successfully completed one of the pivotal parent studies NI-AC301 and NI-AC302 were eligible to roll over into NI-AC303. Those subjects assigned to SB204 once daily (QD) in the parent study continued to receive open label SB204 for 40 more weeks (total ~52 weeks) and are denoted as SB204 experienced. Those subjects assigned to vehicle gel in the parent study were rolled over and received open label SB204 in this trial (total ~40 weeks of SB204 treatment) and are denoted SB204 naive.
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| ID | Title | Description |
|---|---|---|
| FG000 | SB204 4% Experienced | Subjects who received SB204 4% in the parent study (NI-AC301 or NI-AC302) were considered SB204 experienced at the time of enrollment into NI-AC303. |
| FG001 | SB204 Naive |
| 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 | Nov 9, 2015 | Jan 25, 2023 |
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| Baseline, Week 4, Week 12, Week 24, Week 36, Week 40 |
| Inflammatory Lesion Counts by Study Visit | Absolute count of inflammatory lesions at each visit (face only)--safety population | Baseline through Week 40 |
| Non-Inflammatory Lesion Counts by Study Visit | Absolute count of non-inflammatory lesions by study visit (face only) | Baseline through Week 40 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| CIL #189 | Phoenix | Arizona | 85018 | United States |
| CIL #146 | Anaheim | California | 92801 | United States |
| CIL #139 | Cerritos | California | 90703 | United States |
| CIL #216 | Chula Vista | California | 91911 | United States |
| CIL #186 | Fresno | California | 93720 | United States |
| CIL #210 | Fresno | California | 93720 | United States |
| CIL #174 | Huntington Beach | California | 92647 | United States |
| CIL #213 | La Mesa | California | 91942 | United States |
| CIL #209 | Oceanside | California | 92056 | United States |
| CIL #190 | Sacramento | California | 95821 | United States |
| CIL #161 | San Diego | California | 92103 | United States |
| CIL #113 | San Diego | California | 92123 | United States |
| CIL #195 | Santa Ana | California | 92705 | United States |
| CIL #119 | Santa Monica | California | 90404 | United States |
| CIL #199 | Santa Rosa | California | 95405 | United States |
| CIL #103 | Boca Raton | Florida | 33486 | United States |
| CIL #208 | Hialeah | Florida | 33012 | United States |
| CIL #212 | Homestead | Florida | 33030 | United States |
| CIL #222 | Lauderdale Lakes | Florida | 33406 | United States |
| CIL #170 | Miami Lakes | Florida | 33016 | United States |
| CIL #204 | Miami Springs | Florida | 33166 | United States |
| CIL #172 | Orlando | Florida | 32814 | United States |
| CIL #185 | Ormond Beach | Florida | 32174 | United States |
| CIL #203 | Ormond Beach | Florida | 32174 | United States |
| CIL #110 | Pinellas Park | Florida | 33781 | United States |
| CIL #227 | Sanford | Florida | 32771 | United States |
| CIL #211 | South Miami | Florida | 33413 | United States |
| CIL #176 | St. Petersburg | Florida | 33716 | United States |
| CIL #152 | Tampa | Florida | 33607 | United States |
| CIL #229 | Tampa | Florida | 33609 | United States |
| CIL #144 | Tampa | Florida | 33634 | United States |
| CIL #153 | Wellington | Florida | 33414 | 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 #215 | Wichita | Kansas | 67207 | United States |
| CIL #117 | Louisville | Kentucky | 40202 | United States |
| CIL #194 | Richmond | Kentucky | 40475 | United States |
| CIL #219 | Monroe | Louisiana | 71203 | United States |
| CIL #187 | St Louis | Missouri | 63141 | United States |
| CIL #148 | Norfolk | Nebraska | 68701 | 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 #108 | Rochester | New York | 14623 | United States |
| CIL #221 | Salisbury | North Carolina | 28144 | United States |
| CIL #169 | Cincinnati | Ohio | 45246 | United States |
| CIL #226 | Cincinnati | Ohio | 45255 | United States |
| CIL #237 | Gresham | Oregon | 97030 | United States |
| CIL #200 | Portland | Oregon | 97210 | United States |
| CIL #137 | Broomall | Pennsylvania | 19008 | United States |
| CIL #178 | Philadelphia | Pennsylvania | 19103 | United States |
| CIL #217 | Chattanooga | Tennessee | 37421 | United States |
| CIL #198 | Arlington | Texas | 76011 | United States |
| CIL #160 | Austin | Texas | 78735 | United States |
| CIL #154 | Beaumont | Texas | 77701 | United States |
| CIL #184 | Bryan | Texas | 77802 | 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 #106 | Salt Lake City | Utah | 84117 | United States |
| CIL #105 | Lynchburg | Virginia | 24501 | United States |
| CIL #231 | Norfolk | Virginia | 23507 | United States |
Subjects who received vehicle gel in the parent study (NI-AC301 or NI-AC302) were considered SB204 naive at the time of enrollment into this study (NI-AC303). They began treatment with SB204 on the day of enrollment.
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| NOT COMPLETED |
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Safety population. As this was an open label, long term safety study, all subjects were in the safety population.
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| ID | Title | Description |
|---|---|---|
| BG000 | SB204 Experienced | Subjects who were assigned to and received SB204 in the pivotal study (NI-AC301 or NI-AC302) were denoted as being SB204 experienced when they rolled over into the open-label long term safety study (NI-AC303). These subjects were on treatment with SB204 for up to 52 weeks (12 weeks in the pivotal study + 40 weeks in this study. |
| BG001 | SB204 Naive | Subjects who were assigned to and received Vehicle Gel in the pivotal study (NI-AC301 or NI-AC302) were denoted as being SB204 naive when they rolled over into the open-label long term safety study (NI-AC303). These subjects were on treatment with SB204 for up to 40 weeks. |
| 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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| Age, Customized | Count of Participants | Participants |
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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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| Parent study (NI-AC301 or NI-AC302) | 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 | Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303) | This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive. | Safety population There were 59 subjects in the SB204 Experienced group with 104 ongoing AEs at the time of rollover and 62 SB204 Naive subjects with 97 ongoing AEs at the time of rollover. | Posted | Count of Participants | Participants | Baseline |
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| Primary | Number of Subjects With Treatment Emergent Adverse Events | Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303. | Safety population | Posted | Count of Participants | Participants | Week 40/End of Treatment |
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| Secondary | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Analysis of cutaneous tolerability scores at each visit through end of treatment. Baseline is the Week 12 assessment from the previous study (NI-AC301 or NI-AC302). The Cutaneous Tolerability Assessment scale consisted of the investigator's assessment of erythema, scaling, and dryness at the time the assessment was made. Pruritus and burning/stinging were based on the subject's report for the previous 24 hours. Each component was graded on a scale of 0-3, with 0 being none (not present) and 3 being severe. Higher scores indicated a higher severity of reaction. | Safety population: per the Statistical Analysis Plan, data are presented for the combined study population of 601 subjects. | Posted | Number | participants | Baseline, Week 4, Week 12, Week 24, Week 36, Week 40 |
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| Secondary | Inflammatory Lesion Counts by Study Visit | Absolute count of inflammatory lesions at each visit (face only)--safety population | Safety population | Posted | Mean | Standard Deviation | number of inflammatory lesions | Baseline through Week 40 |
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| Secondary | Non-Inflammatory Lesion Counts by Study Visit | Absolute count of non-inflammatory lesions by study visit (face only) | Safety population | Posted | Mean | Standard Deviation | number of non-inflammatory lesions | Baseline through Week 40 |
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Baseline through Week 40 (approximately 9 months)
Treatment emergent adverse events (TEAEs) were defined as AEs reported on or after the first day of enrollment in this long term safety study. They are reported for the combined study safety population (SB204 experienced + SB204 naive).
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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 Experienced | Subjects who received SB204 4% QD in the parent study (NI-AC301 or NI-AC302) and continued to receive open label SB204 4% QD in this study. | 0 | 296 | 4 | 296 | 34 | 296 |
| EG001 | SB204 Naive | Subjects who received vehicle gel QD in the parent study (NI-AC301 or NI-AC302) and SB204 4% QD in this study. | 0 | 305 | 2 | 305 | 32 | 305 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Conduct Disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Application site dryness | 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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| Application site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cathy White, Vice President, Drug Development Operations | Novan | 9194858080 | clinical@novan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2017 | Jan 25, 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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| Adult (≥18 years) |
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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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| NI-AC302 |
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