Trial Outcomes & Findings for P3 Long Term Safety Study of Once Daily SB204 in Acne (NCT NCT02798120)
NCT ID: NCT02798120
Last Updated: 2023-05-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
601 participants
Primary outcome timeframe
Baseline
Results posted on
2023-05-12
Participant Flow
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.
Participant milestones
| Measure |
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.
|
SB204 Naive
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.
|
|---|---|---|
|
Overall Study
STARTED
|
296
|
305
|
|
Overall Study
COMPLETED
|
232
|
216
|
|
Overall Study
NOT COMPLETED
|
64
|
89
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
P3 Long Term Safety Study of Once Daily SB204 in Acne
Baseline characteristics by cohort
| Measure |
SB204 Experienced
n=296 Participants
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.
|
SB204 Naive
n=305 Participants
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.
|
Total
n=601 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.4 years
STANDARD_DEVIATION 8.86 • n=5 Participants
|
21.0 years
STANDARD_DEVIATION 8.66 • n=7 Participants
|
21.2 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
|
Age, Customized
Juvenile (<18 years)
|
133 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Age, Customized
Adult (≥18 years)
|
163 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
174 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
357 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
111 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
185 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
368 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
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
58 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
211 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 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
|
296 Participants
n=5 Participants
|
305 Participants
n=7 Participants
|
601 Participants
n=5 Participants
|
|
Parent study (NI-AC301 or NI-AC302)
NI-AC301
|
150 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
309 Participants
n=5 Participants
|
|
Parent study (NI-AC301 or NI-AC302)
NI-AC302
|
146 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
292 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
SB204 Experienced
n=296 Participants
Subjects who were assigned to the SB204 4% QD treatment group in NI-AC301/NI-AC302.
|
SB204 Naive
n=305 Participants
Subjects who were assigned to the Vehicle Gel QD treatment group in NI-AC301/NI-AC302.
|
|---|---|---|
|
Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)
|
59 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: Week 40/End of TreatmentPopulation: Safety population
Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303.
Outcome measures
| Measure |
SB204 Experienced
n=296 Participants
Subjects who were assigned to the SB204 4% QD treatment group in NI-AC301/NI-AC302.
|
SB204 Naive
n=305 Participants
Subjects who were assigned to the Vehicle Gel QD treatment group in NI-AC301/NI-AC302.
|
|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events
|
54 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 24, Week 36, Week 40Population: Safety population: per the Statistical Analysis Plan, data are presented for the combined study population of 601 subjects.
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.
Outcome measures
| Measure |
SB204 Experienced
n=601 Participants
Subjects who were assigned to the SB204 4% QD treatment group in NI-AC301/NI-AC302.
|
SB204 Naive
Subjects who were assigned to the Vehicle Gel QD treatment group in NI-AC301/NI-AC302.
|
|---|---|---|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Erythema: none (0)
|
387 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Erythema: mild (1)
|
57 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Erythema: moderate (2)
|
4 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Erythema: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Erythema: none (0)
|
419 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Erythema: moderate (2)
|
5 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Erythema: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Erythema: none (0)
|
493 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Erythema: mild (1)
|
80 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Erythema: moderate (2)
|
16 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Erythema: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Erythema: none (0)
|
461 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Erythema: mild (1)
|
109 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Erythema: moderate (2)
|
14 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Erythema: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Erythema: none (0)
|
432 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Erythema: mild (1)
|
84 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Erythema: moderate (2)
|
10 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Erythema: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Erythema: none (0)
|
411 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Erythema: mild (1)
|
66 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Erythema: moderate (2)
|
10 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Erythema: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Erythema: none (0)
|
385 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Erythema: mild (1)
|
60 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET Erythema: mild (1)
|
70 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Erythema: moderate (2)
|
6 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Erythema: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Scaling: none (0)
|
553 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Scaling: mild (1)
|
33 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Scaling: moderate (2)
|
3 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Scaling: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Scaling: none (0)
|
535 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Scaling: mild (1)
|
46 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Scaling: moderate (2)
|
3 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Scaling: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Scaling: none (0)
|
487 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Scaling: mild (1)
|
37 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Scaling: moderate (2)
|
2 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Scaling: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Scaling: none (0)
|
449 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Scaling: mild (1)
|
35 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Scaling: moderate (2)
|
3 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Scaling: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Scaling: none (0)
|
398 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Scaling: mild (1)
|
51 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Scaling: moderate (2)
|
1 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Scaling: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Scaling: none (0)
|
423 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Scaling: mild (1)
|
25 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Scaling: moderate (2)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Scaling: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Scaling: none (0)
|
462 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Scaling: mild (1)
|
32 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Scaling: moderate (2)
|
1 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Scaling: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Dryness: none (0)
|
510 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Dryness: mild (1)
|
73 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Dryness: moderate (2)
|
6 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Dryness: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Dryness: none (0)
|
496 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Dryness: mild (1)
|
82 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Dryness: moderate (2)
|
6 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Dryness: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Dryness: none (0)
|
440 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Dryness: mild (1)
|
82 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Dryness: moderate (2)
|
4 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Dryness: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Dryness: none (0)
|
398 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Dryness: mild (1)
|
80 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Dryness: moderate (1)
|
7 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Dryness: severe (3)
|
2 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Dryness: none (0)
|
382 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Dryness: mild (1)
|
68 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Dryness: moderate (2)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Dryness: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Dryness: none (0)
|
386 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Dryness: mild (1)
|
61 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Dryness: moderate (2)
|
1 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Dryness: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Dryness: none (0)
|
422 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET Dryness: mild (1)
|
70 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Dryness: moderate (2)
|
2 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET Week 40/ET: Dryness: severe (3)
|
1 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Pruritus: none (0)
|
560 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Pruritus: mild (1)
|
26 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Pruritus: moderate (2)
|
3 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline: Pruritus: severe (3) Baseline: Pruritus: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Pruritus: none (0)
|
540 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Pruritus: mild (1)
|
40 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Pruritus: moderate (2)
|
2 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Pruritus: severe (3)
|
2 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Pruritus: none (0)
|
481 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Pruritus: mild (2)
|
40 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Pruritus: moderate (2)
|
3 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Pruritus: severe (3)
|
2 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Pruritus: none (0)
|
454 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Pruritus: Week 24 mild (1)
|
30 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Pruritus: moderate (2)
|
2 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Pruritus: 24 severe (3)
|
1 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Pruritus: none (0)
|
429 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Pruritus: mild (1)
|
18 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Pruritus: moderate (2)
|
2 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Pruritus: severe (3)
|
1 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Pruritus: none (0)
|
418 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Pruritus: mild (1)
|
29 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Pruritus: moderate (2)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Pruritus: severe (3)
|
1 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Pruritus: none (0)
|
457 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Pruritus: mild (1)
|
34 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Pruritus: moderate (2)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Pruritus: severe (3)
|
4 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline Burning/Stinging: none (0)
|
536 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline Burning/Stinging: mild (1)
|
53 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline Burning/Stinging: moderate (2)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Baseline Burning/Stinging: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Burning/Stinging: none (0)
|
512 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Burning/Stinging: mild (1)
|
65 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Burning/Stinging: moderate (2)
|
7 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 4: Burning/Stinging: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Burning/Stinging: none (0)
|
463 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Burning/Stinging: mild (1)
|
56 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Burning/Stinging: moderate (2)
|
7 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 12: Burning/Stinging: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Burning/Stinging: none (0)
|
436 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Burning/Stinging: mild (1)
|
50 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Burning/Stinging: moderate (2)
|
1 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 24: Burning/Stinging: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Burning/Stinging: none (0)
|
422 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Burning/Stinging: mild (1)
|
25 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Burning/Stinging: moderate (2)
|
3 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 36: Burning/Stinging: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Burning/Stinging: none (0)
|
411 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Burning/Stinging: mild
|
36 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Burning/Stinging: moderate (2)
|
1 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40: Burning/Stinging: severe (3)
|
0 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Burning/Stinging: none (0)
|
451 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Burning/Stinging: mild (1)
|
40 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Burning/Stinging: moderate (2)
|
2 participants
|
—
|
|
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Week 40/ET: Burning/Stinging: severe (3)
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 40Population: Safety population
Absolute count of inflammatory lesions at each visit (face only)--safety population
Outcome measures
| Measure |
SB204 Experienced
n=296 Participants
Subjects who were assigned to the SB204 4% QD treatment group in NI-AC301/NI-AC302.
|
SB204 Naive
n=305 Participants
Subjects who were assigned to the Vehicle Gel QD treatment group in NI-AC301/NI-AC302.
|
|---|---|---|
|
Inflammatory Lesion Counts by Study Visit
Baseline
|
13.2 number of inflammatory lesions
Standard Deviation 9.94
|
15.3 number of inflammatory lesions
Standard Deviation 10.81
|
|
Inflammatory Lesion Counts by Study Visit
Week 4
|
12.2 number of inflammatory lesions
Standard Deviation 9.98
|
14.3 number of inflammatory lesions
Standard Deviation 10.27
|
|
Inflammatory Lesion Counts by Study Visit
Week 12
|
10.8 number of inflammatory lesions
Standard Deviation 9.66
|
13.1 number of inflammatory lesions
Standard Deviation 9.74
|
|
Inflammatory Lesion Counts by Study Visit
Week 24
|
10.3 number of inflammatory lesions
Standard Deviation 7.5
|
11.4 number of inflammatory lesions
Standard Deviation 9.41
|
|
Inflammatory Lesion Counts by Study Visit
Week 36
|
8.3 number of inflammatory lesions
Standard Deviation 8.39
|
9.7 number of inflammatory lesions
Standard Deviation 9.11
|
|
Inflammatory Lesion Counts by Study Visit
Week 40
|
7.3 number of inflammatory lesions
Standard Deviation 8.13
|
8.9 number of inflammatory lesions
Standard Deviation 8.99
|
|
Inflammatory Lesion Counts by Study Visit
Week 40/ET
|
7.9 number of inflammatory lesions
Standard Deviation 8.47
|
9.8 number of inflammatory lesions
Standard Deviation 9.46
|
SECONDARY outcome
Timeframe: Baseline through Week 40Population: Safety population
Absolute count of non-inflammatory lesions by study visit (face only)
Outcome measures
| Measure |
SB204 Experienced
n=296 Participants
Subjects who were assigned to the SB204 4% QD treatment group in NI-AC301/NI-AC302.
|
SB204 Naive
n=305 Participants
Subjects who were assigned to the Vehicle Gel QD treatment group in NI-AC301/NI-AC302.
|
|---|---|---|
|
Non-Inflammatory Lesion Counts by Study Visit
Week 4
|
21.9 number of non-inflammatory lesions
Standard Deviation 16.27
|
23.0 number of non-inflammatory lesions
Standard Deviation 16.07
|
|
Non-Inflammatory Lesion Counts by Study Visit
Week 12
|
19.7 number of non-inflammatory lesions
Standard Deviation 15.14
|
21.5 number of non-inflammatory lesions
Standard Deviation 16.09
|
|
Non-Inflammatory Lesion Counts by Study Visit
Week 24
|
17.2 number of non-inflammatory lesions
Standard Deviation 14.67
|
17.5 number of non-inflammatory lesions
Standard Deviation 13.20
|
|
Non-Inflammatory Lesion Counts by Study Visit
Week 36
|
14.0 number of non-inflammatory lesions
Standard Deviation 13.19
|
15.4 number of non-inflammatory lesions
Standard Deviation 13.06
|
|
Non-Inflammatory Lesion Counts by Study Visit
Week 40
|
12.6 number of non-inflammatory lesions
Standard Deviation 13.77
|
14.1 number of non-inflammatory lesions
Standard Deviation 12.59
|
|
Non-Inflammatory Lesion Counts by Study Visit
Week 40/ET
|
13.7 number of non-inflammatory lesions
Standard Deviation 14.64
|
15.4 number of non-inflammatory lesions
Standard Deviation 14.70
|
|
Non-Inflammatory Lesion Counts by Study Visit
Baseline
|
23.6 number of non-inflammatory lesions
Standard Deviation 16.08
|
25.5 number of non-inflammatory lesions
Standard Deviation 18.32
|
Adverse Events
SB204 Experienced
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
SB204 Naive
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB204 Experienced
n=296 participants at risk
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.
|
SB204 Naive
n=305 participants at risk
Subjects who received vehicle gel QD in the parent study (NI-AC301 or NI-AC302) and SB204 4% QD in this study.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.34%
1/296 • Number of events 1 • 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).
|
0.00%
0/305 • 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).
|
|
Infections and infestations
Sepsis
|
0.00%
0/296 • 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).
|
0.33%
1/305 • Number of events 1 • 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).
|
|
Psychiatric disorders
Anxiety
|
0.34%
1/296 • Number of events 1 • 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).
|
0.00%
0/305 • 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).
|
|
Psychiatric disorders
Conduct Disorder
|
0.34%
1/296 • Number of events 1 • 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).
|
0.00%
0/305 • 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).
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.34%
1/296 • Number of events 1 • 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).
|
0.00%
0/305 • 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).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/296 • 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).
|
0.33%
1/305 • Number of events 1 • 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).
|
Other adverse events
| Measure |
SB204 Experienced
n=296 participants at risk
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.
|
SB204 Naive
n=305 participants at risk
Subjects who received vehicle gel QD in the parent study (NI-AC301 or NI-AC302) and SB204 4% QD in this study.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.7%
5/296 • 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).
|
4.6%
14/305 • 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).
|
|
Infections and infestations
Influenza
|
1.4%
4/296 • 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).
|
0.98%
3/305 • 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).
|
|
General disorders
Application site dryness
|
2.7%
8/296 • 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).
|
0.98%
3/305 • 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).
|
|
General disorders
Application site pruritus
|
1.0%
3/296 • 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).
|
2.0%
6/305 • 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).
|
|
General disorders
Application site pain
|
1.0%
3/296 • 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).
|
1.3%
4/305 • 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).
|
|
Nervous system disorders
Headache
|
2.4%
7/296 • 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).
|
0.33%
1/305 • 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).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
4/296 • 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).
|
0.66%
2/305 • 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).
|
Additional Information
Cathy White, Vice President, Drug Development Operations
Novan
Phone: 9194858080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place