Trial Outcomes & Findings for P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne (NCT NCT02667444)
NCT ID: NCT02667444
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
1330 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2023-07-24
Participant Flow
Participant milestones
| Measure |
SB204 4%
SB204 4%: Applied topically once daily
|
Vehicle Gel
Vehicle Gel: Applied topically once daily
|
|---|---|---|
|
Overall Study
STARTED
|
664
|
666
|
|
Overall Study
COMPLETED
|
576
|
574
|
|
Overall Study
NOT COMPLETED
|
88
|
92
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
Baseline characteristics by cohort
| Measure |
SB204 4%
n=663 Participants
SB204 4%: Applied topically once daily
|
Vehicle Gel
n=664 Participants
Vehicle Gel: Applied topically once daily
|
Total
n=1327 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.4 years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
21.8 years
STANDARD_DEVIATION 8.77 • n=7 Participants
|
21.6 years
STANDARD_DEVIATION 8.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
411 Participants
n=5 Participants
|
398 Participants
n=7 Participants
|
809 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
252 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
518 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
202 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
461 Participants
n=5 Participants
|
455 Participants
n=7 Participants
|
916 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
158 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
449 Participants
n=5 Participants
|
457 Participants
n=7 Participants
|
906 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
663 Participants
n=5 Participants
|
664 Participants
n=7 Participants
|
1327 Participants
n=5 Participants
|
|
Baseline Investigator Global Assessment
0--clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator Global Assessment
1--almost clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator Global Assessment
2--mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator Global Assessment
3--moderate
|
599 Participants
n=5 Participants
|
587 Participants
n=7 Participants
|
1186 Participants
n=5 Participants
|
|
Baseline Investigator Global Assessment
4--severe
|
64 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT) population
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=663 Participants
SB204 4%: Applied topically once daily
|
Vehicle Gel
n=664 Participants
Vehicle Gel: Applied topically once daily
|
|---|---|---|
|
Absolute Change From Baseline in Inflammatory Lesion Counts
|
-13.1 inflammatory acne lesions
Standard Deviation 10.27
|
-10.9 inflammatory acne lesions
Standard Deviation 10.81
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT) population
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=663 Participants
SB204 4%: Applied topically once daily
|
Vehicle Gel
n=664 Participants
Vehicle Gel: Applied topically once daily
|
|---|---|---|
|
Absolute Change From Baseline in Non-inflammatory Lesion Counts
|
-15.3 non-inflammatory acne lesions
Standard Deviation 14.30
|
-12.7 non-inflammatory acne lesions
Standard Deviation 16.01
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to treat (ITT) population; subjects who had Week 12 (study completion) visits.
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=592 Participants
SB204 4%: Applied topically once daily
|
Vehicle Gel
n=603 Participants
Vehicle Gel: Applied topically once daily
|
|---|---|---|
|
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12
|
120 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT) population
The percent change from baseline in inflammatory lesion count
Outcome measures
| Measure |
SB204 4%
n=663 Participants
SB204 4%: Applied topically once daily
|
Vehicle Gel
n=664 Participants
Vehicle Gel: Applied topically once daily
|
|---|---|---|
|
Percent Change in Inflammatory Lesion Count
|
-48.5 Percentage change from baseline
Standard Deviation 36.36
|
-39.2 Percentage change from baseline
Standard Deviation 38.20
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT) population
The percent change from baseline in non-inflammatory lesion count
Outcome measures
| Measure |
SB204 4%
n=663 Participants
SB204 4%: Applied topically once daily
|
Vehicle Gel
n=664 Participants
Vehicle Gel: Applied topically once daily
|
|---|---|---|
|
Percent Change in Non-inflammatory Lesion Count
|
-40.5 Percentage change from baseline
Standard Deviation 36.35
|
-33.1 Percentage change from baseline
Standard Deviation 39.59
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to treat (ITT) population
Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis)
Outcome measures
| Measure |
SB204 4%
n=485 Participants
SB204 4%: Applied topically once daily
|
Vehicle Gel
n=436 Participants
Vehicle Gel: Applied topically once daily
|
|---|---|---|
|
Time to Reduction in Inflammatory Lesion Count
|
38.0 Days
Interval 31.0 to 56.0
|
56.0 Days
Interval 35.0 to 57.0
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis)
Outcome measures
| Measure |
SB204 4%
n=164 Participants
SB204 4%: Applied topically once daily
|
Vehicle Gel
n=124 Participants
Vehicle Gel: Applied topically once daily
|
|---|---|---|
|
Time to Improvement in IGA
25% Quartile
|
85.0 Days
Interval 85.0 to 86.0
|
87.0 Days
Interval 86.0 to 91.0
|
|
Time to Improvement in IGA
50% Quartile (Median)
|
NA Days
The median and 95% CI were not estimable because fewer than 50% of subjects achieved a change of 2 or more in their IGA assessment.
|
NA Days
The median and 95% CI were not estimable because fewer than 50% of subjects achieved a change of 2 or more in their IGA assessment.
|
|
Time to Improvement in IGA
75% Quartile
|
NA Days
The median and 95% CI were not estimable because not enough subjects achieved a change of 2 or more in their IGA assessment.
|
NA Days
The median and 95% CI were not estimable because not enough subjects achieved a change of 2 or more in their IGA assessment.
|
Adverse Events
SB204 4%
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Vehicle Gel
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB204 4%
n=666 participants at risk
SB204 4%: Applied topically once daily
|
Vehicle Gel
n=661 participants at risk
Vehicle Gel: Applied topically once daily
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
0.15%
1/666 • 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.
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.
|
0.00%
0/661 • 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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/666 • 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.
|
0.15%
1/661 • 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.
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.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/666 • 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.
|
0.15%
1/661 • 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.
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.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/666 • 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.
|
0.15%
1/661 • 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.
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.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/666 • 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.
|
0.15%
1/661 • 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.
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.
|
|
Nervous system disorders
Subarachnoid haemorhage
|
0.00%
0/666 • 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.
|
0.15%
1/661 • 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.
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.
|
Other adverse events
| Measure |
SB204 4%
n=666 participants at risk
SB204 4%: Applied topically once daily
|
Vehicle Gel
n=661 participants at risk
Vehicle Gel: Applied topically once daily
|
|---|---|---|
|
Nervous system disorders
Headache
|
1.5%
10/666 • 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.
|
0.15%
1/661 • 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.
|
|
General disorders
Application site pain
|
2.1%
14/666 • 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.
|
0.61%
4/661 • 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.
|
|
General disorders
Application site erythema
|
1.5%
10/666 • 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.
|
0.30%
2/661 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
15/666 • 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.
|
2.7%
18/661 • 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.
|
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