Trial Outcomes & Findings for P3 Study in Acne Comparing Once Daily SB204 and Vehicle (NCT NCT02672332)
NCT ID: NCT02672332
Last Updated: 2023-07-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1307 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2023-07-24
Participant Flow
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.
Participant milestones
| Measure |
SB204 4%
SB204 4% topically once daily
|
Vehicle Gel
Vehicle Gel (placebo comparator) topically once daily
|
|---|---|---|
|
Overall Study
STARTED
|
653
|
654
|
|
Overall Study
COMPLETED
|
571
|
577
|
|
Overall Study
NOT COMPLETED
|
82
|
77
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
Baseline characteristics by cohort
| Measure |
SB204 4%
n=652 Participants
SB204 4% topically once daily
|
Vehicle Gel
n=654 Participants
Vehicle Gel (placebo comparator) topically once daily
|
Total
n=1306 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.1 years
STANDARD_DEVIATION 8.25 • n=652 Participants
|
21.3 years
STANDARD_DEVIATION 8.38 • n=654 Participants
|
21.2 years
STANDARD_DEVIATION 8.32 • n=1306 Participants
|
|
Sex: Female, Male
Female
|
400 Participants
n=652 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
406 Participants
n=654 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
806 Participants
n=1306 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
|
Sex: Female, Male
Male
|
252 Participants
n=652 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
248 Participants
n=654 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
500 Participants
n=1306 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=652 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
2 Participants
n=654 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
5 Participants
n=1306 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=652 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
26 Participants
n=654 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
54 Participants
n=1306 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=652 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
2 Participants
n=654 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
4 Participants
n=1306 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
|
Race (NIH/OMB)
Black or African American
|
143 Participants
n=652 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
148 Participants
n=654 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
291 Participants
n=1306 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
|
Race (NIH/OMB)
White
|
456 Participants
n=652 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
455 Participants
n=654 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
911 Participants
n=1306 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=652 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
0 Participants
n=654 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
0 Participants
n=1306 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=652 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
21 Participants
n=654 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
41 Participants
n=1306 Participants • One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.
|
|
Region of Enrollment
United States
|
652 Participants
n=652 Participants
|
654 Participants
n=654 Participants
|
1306 Participants
n=1306 Participants
|
|
Baseline Investigator Global Assessment
0--clear
|
0 Participants
n=651 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
0 Participants
n=653 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
0 Participants
n=1304 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
|
Baseline Investigator Global Assessment
1--almost clear
|
0 Participants
n=651 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
0 Participants
n=653 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
0 Participants
n=1304 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
|
Baseline Investigator Global Assessment
2--mild
|
0 Participants
n=651 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
0 Participants
n=653 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
0 Participants
n=1304 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
|
Baseline Investigator Global Assessment
3--moderate
|
557 Participants
n=651 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
575 Participants
n=653 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
1132 Participants
n=1304 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
|
Baseline Investigator Global Assessment
4--severe
|
94 Participants
n=651 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
78 Participants
n=653 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
172 Participants
n=1304 Participants • Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent To Treat population (ITT)
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.
Outcome measures
| Measure |
SB204 4%
n=651 Participants
SB204 4% topically once daily
|
Vehicle Gel
n=653 Participants
Vehicle Gel (placebo comparator) topically once daily
|
|---|---|---|
|
Absolute Change From Baseline in Inflammatory Lesion Counts
|
-12.4 inflammatory acne lesions
Standard Deviation 10.30
|
-11.3 inflammatory acne lesions
Standard Deviation 10.46
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat population (ITT)
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).
Outcome measures
| Measure |
SB204 4%
n=651 Participants
SB204 4% topically once daily
|
Vehicle Gel
n=653 Participants
Vehicle Gel (placebo comparator) topically once daily
|
|---|---|---|
|
Absolute Change From Baseline in Non-inflammatory Lesion Counts
|
-16.0 non-inflammatory acne lesions
Standard Deviation 16.36
|
-13.5 non-inflammatory acne lesions
Standard Deviation 16.97
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: ITT population; subjects who had a Week 12 (study completion) visit.
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
Outcome measures
| Measure |
SB204 4%
n=599 Participants
SB204 4% topically once daily
|
Vehicle Gel
n=592 Participants
Vehicle Gel (placebo comparator) topically once daily
|
|---|---|---|
|
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12
|
83 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population.
The percent change from baseline in inflammatory lesion count
Outcome measures
| Measure |
SB204 4%
n=651 Participants
SB204 4% topically once daily
|
Vehicle Gel
n=653 Participants
Vehicle Gel (placebo comparator) topically once daily
|
|---|---|---|
|
Percent Change in Inflammatory Lesion Count
|
-45.9 Percentage change from baseline
Standard Deviation 36.65
|
-43.1 Percentage change from baseline
Standard Deviation 38.68
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population
The percent change from baseline in non-inflammatory lesion count
Outcome measures
| Measure |
SB204 4%
n=651 Participants
SB204 4% topically once daily
|
Vehicle Gel
n=653 Participants
Vehicle Gel (placebo comparator) topically once daily
|
|---|---|---|
|
Percent Change in Non-inflammatory Lesion Count
|
-39.6 Percentage change from baseline
Standard Deviation 35.84
|
-34.6 Percentage change from baseline
Standard Deviation 41.82
|
SECONDARY outcome
Timeframe: Week 12Population: ITT population; overall number of participants analyzed = the # of participants who achieved at least a 35% reduction in their inflammatory lesion counts.
Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier)
Outcome measures
| Measure |
SB204 4%
n=506 Participants
SB204 4% topically once daily
|
Vehicle Gel
n=494 Participants
Vehicle Gel (placebo comparator) topically once daily
|
|---|---|---|
|
Time to Reduction in Inflammatory Lesion Counts
|
31.0 Days
Interval 30.0 to 37.0
|
31.0 Days
Interval 29.0 to 55.0
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis).
Outcome measures
| Measure |
SB204 4%
n=133 Participants
SB204 4% topically once daily
|
Vehicle Gel
n=120 Participants
Vehicle Gel (placebo comparator) topically once daily
|
|---|---|---|
|
Time to Improvement in IGA
25% Quartile
|
87.0 Days
Interval 86.0 to 90.0
|
87.0 Days
Interval 86.0 to
The upper bounds of the CI is not available because not enough subjects achieved a 2 or more grade improvement in their IGA score prior to their last visit.
|
|
Time to Improvement in IGA
50% Quartile
|
NA Days
The median was not estimable due to \< 50% of subjects achieving a 2 or more grade improvement in their IGA score.
|
NA Days
The median was not estimable due to \< 50% of subjects achieving a 2 or more grade improvement in their IGA score.
|
|
Time to Improvement in IGA
75% Quartile
|
NA Days
The median was not estimable due to \< 50% of subjects achieving a 2 or more grade improvement in their IGA score.
|
NA Days
The median was not estimable due to \< 50% of subjects achieving a 2 or more grade improvement in their IGA score.
|
Adverse Events
SB204 4%
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Vehicle Gel
Serious events: 4 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SB204 4%
n=654 participants at risk
SB204 4% topically once daily
|
Vehicle Gel
n=652 participants at risk
Vehicle Gel (placebo comparator) topically once daily
|
|---|---|---|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/654 • 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.
|
0.15%
1/652 • Number of events 1 • 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.
|
|
General disorders
Death
|
0.00%
0/654 • 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.
|
0.15%
1/652 • Number of events 1 • 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.
|
|
Nervous system disorders
Seizure
|
0.00%
0/654 • 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.
|
0.15%
1/652 • Number of events 1 • 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.
|
|
Psychiatric disorders
Bulimia nervosa
|
0.00%
0/654 • 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.
|
0.15%
1/652 • Number of events 1 • 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.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/654 • 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.
|
0.15%
1/652 • Number of events 1 • 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.
|
Other adverse events
| Measure |
SB204 4%
n=654 participants at risk
SB204 4% topically once daily
|
Vehicle Gel
n=652 participants at risk
Vehicle Gel (placebo comparator) topically once daily
|
|---|---|---|
|
General disorders
Application site pain
|
3.2%
21/654 • 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.
|
0.46%
3/652 • 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.
|
|
General disorders
Application site pruritus
|
2.4%
16/654 • 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.
|
0.46%
3/652 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
11/654 • 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.
|
1.5%
10/652 • 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.
|
|
General disorders
Application site erythema
|
1.7%
11/654 • 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.
|
0.15%
1/652 • 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.
|
|
General disorders
Application site dryness
|
1.1%
7/654 • 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.
|
0.31%
2/652 • 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.
|
Additional Information
Cathy White, Vice President, Drug Development Operations
Novan, Inc.
Phone: 919-485-8080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place