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This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.
A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB204 2% Twice daily | Experimental | Twice daily SB204 2% |
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| SB204 4% daily | Experimental | Once daily SB204 4% |
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| Vehicle Gel Daily | Placebo Comparator | Vehicle Gel Daily |
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| Vehicle Gel Twice Daily | Placebo Comparator | Twice daily Vehicle Gel |
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| SB204 4% Twice Daily | Experimental | Twice daily SB204 4% |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB204 2% | Drug | Applied topically twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Inflammatory Lesion Counts | Change in inflammatory lesion count from Baseline to Week 12 | Baseline and Week 12 |
| Absolute Change in Non-inflammatory Lesion Counts | Absolute Change in non-inflammatory lesion count from Baseline to Week 12 | Baseline and Week 12 |
| Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment | Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions) | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Inflammatory Lesion Count From Baseline to Week 12 | The percent change in inflammatory lesion count from Baseline to Week 12 | Baseline and Week 12 |
| Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M J Rico, MD | Novan, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qst acne site #1 | Hot Springs | Arkansas | 71913 | United States | ||
| QST Site #118 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle Gel QD | Vehicle Gel: Applied topically once daily |
| FG001 | Vehicle Gel BID | Vehicle Gel: Applied topically twice 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 | Oct 16, 2014 | Mar 17, 2023 |
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| SB204 4% | Drug | Applied topically daily |
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| Vehicle Gel | Drug | Applied topically twice and once daily |
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The percent change in non-inflammatory lesion count from Baseline to Week 12
| Baseline and Week 12 |
| Median Time to Improvement | Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure. | Baseline through Week 12 |
| Encinitas |
| California |
| 92024 |
| United States |
| QST Site #111 | San Diego | California | 92123 | United States |
| QST Site #113 | San Diego | California | 92123 | United States |
| QST Site #119 | Santa Monica | California | 90404 | United States |
| QST Site #103 | Boca Raton | Florida | 33486 | United States |
| QST Site # 110 | Pinellas Park | Florida | 33781 | United States |
| QST Site # 116 | Newnan | Georgia | 302636 | United States |
| QST Site #117 | Louisville | Kentucky | 40202 | United States |
| QST Site #112 | Detroit | Michigan | 48202 | United States |
| QST Site #120 | Warren | Michigan | 48088 | United States |
| QST Site # 121 | Minneapolis | Minnesota | 55432 | United States |
| QST Site #107 | New York | New York | 10155 | United States |
| QST Site #108 | Rochester | New York | 14623 | United States |
| QST Site #109 | Rochester | New York | 14625 | United States |
| QST Site #104 | Stony Brook | New York | 11790 | United States |
| QST Site # 102 | San Antonio | Texas | 78229 | United States |
| QST Site #106 | Salt Lake City | Utah | 84117 | United States |
| QST #105 | Lynchburg | Virginia | 24501 | United States |
| QST Site #114 | Norfolk | Virginia | 23507 | United States |
| FG002 | SB204 2% BID | SB204 2%: Applied topically twice daily |
| FG003 | SB204 4% QD | SB204 4%: Applied topically once daily |
| FG004 | SB204 4% BID | SB204 4%: Applied topically twice daily |
| Number of Subjects Excluded From ITT Population | One subject in the SB204 4% BID group was not dispensed study medication after randomization. |
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| 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. One subject in the SB204 4% BID group was randomized but did not receive study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle Gel QD | Vehicle Gel: Applied topically once daily |
| BG001 | Vehicle Gel BID | Vehicle Gel: Applied topically twice daily |
| BG002 | SB204 2% BID | SB204 2%: Applied topically twice daily |
| BG003 | SB204 4% QD | SB204 4%: Applied topically once daily |
| BG004 | SB204 4% BID | SB204 4%: Applied topically twice daily |
| BG005 | 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 | The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6. | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6. | 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 in Inflammatory Lesion Counts | Change in inflammatory lesion count from Baseline to Week 12 | Intent to treat population (ITT) | Posted | Mean | Standard Deviation | inflammatory acne lesions | Baseline and Week 12 |
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| Primary | Absolute Change in Non-inflammatory Lesion Counts | Absolute Change in non-inflammatory lesion count from Baseline to Week 12 | Intent to treat (ITT) population | Posted | Mean | Standard Deviation | non-inflammatory acne lesions | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment | Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions) | Intent to treat (ITT) population. Count of participants = number of participants achieving success on the Investigator's Global Assessment at Week 12: a score of clear (0) or almost clear (1) and at least 2 grades less than Baseline. | Posted | Count of Participants | Participants | Baseline and Week 12 |
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| Secondary | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 | The percent change in inflammatory lesion count from Baseline to Week 12 | 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 From Baseline to Week 12 | The percent change in non-inflammatory lesion count from Baseline to Week 12 | Intent to treat (ITT) population | Posted | Mean | Standard Deviation | Percentage change from baseline | Baseline and Week 12 |
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| Secondary | Median Time to Improvement | Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure. | Intent to treat (ITT) population. The vehicle QD and vehicle BID arms were combined per the study Statistical Analysis Plan: "Median time to improvement will be calculated using the Kaplan-Meier method, and the Kaplan-Meier curves will be presented for each active treatment group and the combined Vehicle group." | Posted | Median | Full Range | Weeks | Baseline through Week 12 |
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Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
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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 | Vehicle Gel QD | Vehicle Gel: Applied topically once daily | 0 | 26 | 0 | 26 | 1 | 26 |
| EG001 | Vehicle Gel BID | Vehicle Gel: Applied topically twice daily | 0 | 29 | 0 | 29 | 4 | 29 |
| EG002 | SB204 2% BID | SB204 2%: Applied topically twice daily | 0 | 53 | 0 | 53 | 4 | 53 |
| EG003 | SB204 4% QD | SB204 4%: Applied topically once daily | 0 | 52 | 1 | 52 | 5 | 52 |
| EG004 | SB204 4% BID | SB204 4%: Applied topically twice daily | 0 | 51 | 0 | 51 | 3 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | Event required hospitalization; considered unlikely to be related to study drug. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dryness | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | 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 | May 19, 2015 | Mar 17, 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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| Vehicle |
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| Vehicle |
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| Vehicle |
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| Vehicle |
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| Units | Counts |
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| OG002 | SB204 2% BID | SB204 2%: Applied topically twice daily |
| OG003 | SB204 4% QD | SB204 4%: Applied topically once daily |
| OG004 | SB204 4% BID | SB204 4%: Applied topically twice daily |
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| Participants |
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| Units | Counts |
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| Participants |
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| Unknown or Not Reported |
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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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