Acne Vulgaris
Conditions
Brief summary
This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.
Detailed description
A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris.
Interventions
DRUGSB204 4%
Open label, topical SB204 4%
Sponsors
Chiltern International Inc.
Novan, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Have completed 12 weeks of treatment in NI-AC301 or NI-AC302
Exclusion criteria
* Terminated early from an SB204 Phase 3 pivotal study for any reason * Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application * Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303) | Baseline | 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. |
| Number of Subjects With Treatment Emergent Adverse Events | Week 40/End of Treatment | Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Lesion Counts by Study Visit | Baseline through Week 40 | Absolute count of inflammatory lesions at each visit (face only)--safety population |
| Non-Inflammatory Lesion Counts by Study Visit | Baseline through Week 40 | Absolute count of non-inflammatory lesions by study visit (face only) |
| Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline, Week 4, Week 12, Week 24, Week 36, Week 40 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| SB204 Experienced Subjects who were assigned to and received SB204 in the pivotal study (NI-AC301 or NI-AC302) were denoted as being SB204 experienced when they rolled over into the open-label long term safety study (NI-AC303). These subjects were on treatment with SB204 for up to 52 weeks (12 weeks in the pivotal study + 40 weeks in this study. | 296 |
| SB204 Naive Subjects who were assigned to and received Vehicle Gel in the pivotal study (NI-AC301 or NI-AC302) were denoted as being SB204 naive when they rolled over into the open-label long term safety study (NI-AC303). These subjects were on treatment with SB204 for up to 40 weeks. | 305 |
| Total | 601 |
Baseline characteristics
| Characteristic | SB204 Naive | SB204 Experienced | Total |
|---|---|---|---|
| Age, Continuous | 21.0 years STANDARD_DEVIATION 8.66 | 21.4 years STANDARD_DEVIATION 8.86 | 21.2 years STANDARD_DEVIATION 8.76 |
| Age, Customized Adult (≥18 years) | 156 Participants | 163 Participants | 319 Participants |
| Age, Customized Juvenile (<18 years) | 149 Participants | 133 Participants | 282 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 122 Participants | 111 Participants | 233 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 183 Participants | 185 Participants | 368 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Parent study (NI-AC301 or NI-AC302) NI-AC301 | 159 Participants | 150 Participants | 309 Participants |
| Parent study (NI-AC301 or NI-AC302) NI-AC302 | 146 Participants | 146 Participants | 292 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 19 Participants | 23 Participants | 42 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 58 Participants | 114 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 221 Participants | 211 Participants | 432 Participants |
| Region of Enrollment United States | 305 Participants | 296 Participants | 601 Participants |
| Sex: Female, Male Female | 183 Participants | 174 Participants | 357 Participants |
| Sex: Female, Male Male | 122 Participants | 122 Participants | 244 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 296 | 0 / 305 |
| other Total, other adverse events | 34 / 296 | 32 / 305 |
| serious Total, serious adverse events | 4 / 296 | 2 / 305 |
Outcome results
Primary
Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)
This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB204 Experienced | Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303) | 59 Participants |
| SB204 Naive | Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303) | 62 Participants |
Primary
Number of Subjects With Treatment Emergent Adverse Events
Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303.
Time frame: Week 40/End of Treatment
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB204 Experienced | Number of Subjects With Treatment Emergent Adverse Events | 54 Participants |
| SB204 Naive | Number of Subjects With Treatment Emergent Adverse Events | 58 Participants |
Secondary
Inflammatory Lesion Counts by Study Visit
Absolute count of inflammatory lesions at each visit (face only)--safety population
Time frame: Baseline through Week 40
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB204 Experienced | Inflammatory Lesion Counts by Study Visit | Week 12 | 10.8 number of inflammatory lesions | Standard Deviation 9.66 |
| SB204 Experienced | Inflammatory Lesion Counts by Study Visit | Week 36 | 8.3 number of inflammatory lesions | Standard Deviation 8.39 |
| SB204 Experienced | Inflammatory Lesion Counts by Study Visit | Week 4 | 12.2 number of inflammatory lesions | Standard Deviation 9.98 |
| SB204 Experienced | Inflammatory Lesion Counts by Study Visit | Week 40 | 7.3 number of inflammatory lesions | Standard Deviation 8.13 |
| SB204 Experienced | Inflammatory Lesion Counts by Study Visit | Week 24 | 10.3 number of inflammatory lesions | Standard Deviation 7.5 |
| SB204 Experienced | Inflammatory Lesion Counts by Study Visit | Week 40/ET | 7.9 number of inflammatory lesions | Standard Deviation 8.47 |
| SB204 Experienced | Inflammatory Lesion Counts by Study Visit | Baseline | 13.2 number of inflammatory lesions | Standard Deviation 9.94 |
| SB204 Naive | Inflammatory Lesion Counts by Study Visit | Week 40/ET | 9.8 number of inflammatory lesions | Standard Deviation 9.46 |
| SB204 Naive | Inflammatory Lesion Counts by Study Visit | Baseline | 15.3 number of inflammatory lesions | Standard Deviation 10.81 |
| SB204 Naive | Inflammatory Lesion Counts by Study Visit | Week 4 | 14.3 number of inflammatory lesions | Standard Deviation 10.27 |
| SB204 Naive | Inflammatory Lesion Counts by Study Visit | Week 12 | 13.1 number of inflammatory lesions | Standard Deviation 9.74 |
| SB204 Naive | Inflammatory Lesion Counts by Study Visit | Week 24 | 11.4 number of inflammatory lesions | Standard Deviation 9.41 |
| SB204 Naive | Inflammatory Lesion Counts by Study Visit | Week 36 | 9.7 number of inflammatory lesions | Standard Deviation 9.11 |
| SB204 Naive | Inflammatory Lesion Counts by Study Visit | Week 40 | 8.9 number of inflammatory lesions | Standard Deviation 8.99 |
Secondary
Non-Inflammatory Lesion Counts by Study Visit
Absolute count of non-inflammatory lesions by study visit (face only)
Time frame: Baseline through Week 40
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB204 Experienced | Non-Inflammatory Lesion Counts by Study Visit | Week 12 | 19.7 number of non-inflammatory lesions | Standard Deviation 15.14 |
| SB204 Experienced | Non-Inflammatory Lesion Counts by Study Visit | Week 36 | 14.0 number of non-inflammatory lesions | Standard Deviation 13.19 |
| SB204 Experienced | Non-Inflammatory Lesion Counts by Study Visit | Week 4 | 21.9 number of non-inflammatory lesions | Standard Deviation 16.27 |
| SB204 Experienced | Non-Inflammatory Lesion Counts by Study Visit | Week 40 | 12.6 number of non-inflammatory lesions | Standard Deviation 13.77 |
| SB204 Experienced | Non-Inflammatory Lesion Counts by Study Visit | Week 24 | 17.2 number of non-inflammatory lesions | Standard Deviation 14.67 |
| SB204 Experienced | Non-Inflammatory Lesion Counts by Study Visit | Week 40/ET | 13.7 number of non-inflammatory lesions | Standard Deviation 14.64 |
| SB204 Experienced | Non-Inflammatory Lesion Counts by Study Visit | Baseline | 23.6 number of non-inflammatory lesions | Standard Deviation 16.08 |
| SB204 Naive | Non-Inflammatory Lesion Counts by Study Visit | Week 40/ET | 15.4 number of non-inflammatory lesions | Standard Deviation 14.7 |
| SB204 Naive | Non-Inflammatory Lesion Counts by Study Visit | Baseline | 25.5 number of non-inflammatory lesions | Standard Deviation 18.32 |
| SB204 Naive | Non-Inflammatory Lesion Counts by Study Visit | Week 4 | 23.0 number of non-inflammatory lesions | Standard Deviation 16.07 |
| SB204 Naive | Non-Inflammatory Lesion Counts by Study Visit | Week 12 | 21.5 number of non-inflammatory lesions | Standard Deviation 16.09 |
| SB204 Naive | Non-Inflammatory Lesion Counts by Study Visit | Week 24 | 17.5 number of non-inflammatory lesions | Standard Deviation 13.2 |
| SB204 Naive | Non-Inflammatory Lesion Counts by Study Visit | Week 36 | 15.4 number of non-inflammatory lesions | Standard Deviation 13.06 |
| SB204 Naive | Non-Inflammatory Lesion Counts by Study Visit | Week 40 | 14.1 number of non-inflammatory lesions | Standard Deviation 12.59 |
Secondary
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Analysis of cutaneous tolerability scores at each visit through end of treatment. Baseline is the Week 12 assessment from the previous study (NI-AC301 or NI-AC302). The Cutaneous Tolerability Assessment scale consisted of the investigator's assessment of erythema, scaling, and dryness at the time the assessment was made. Pruritus and burning/stinging were based on the subject's report for the previous 24 hours. Each component was graded on a scale of 0-3, with 0 being none (not present) and 3 being severe. Higher scores indicated a higher severity of reaction.
Time frame: Baseline, Week 4, Week 12, Week 24, Week 36, Week 40
Population: Safety population: per the Statistical Analysis Plan, data are presented for the combined study population of 601 subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Erythema: none (0) | 493 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Erythema: mild (1) | 80 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Erythema: moderate (2) | 16 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Erythema: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Erythema: none (0) | 461 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Erythema: mild (1) | 109 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Erythema: moderate (2) | 14 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Erythema: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Erythema: none (0) | 432 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Erythema: mild (1) | 84 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Erythema: moderate (2) | 10 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Erythema: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Erythema: none (0) | 411 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Erythema: mild (1) | 66 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Erythema: moderate (2) | 10 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Erythema: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Erythema: none (0) | 385 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Erythema: mild (1) | 60 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Erythema: moderate (2) | 5 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Erythema: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Erythema: none (0) | 387 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Erythema: mild (1) | 57 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Erythema: moderate (2) | 4 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Erythema: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Erythema: none (0) | 419 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET Erythema: mild (1) | 70 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Erythema: moderate (2) | 6 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Erythema: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Scaling: none (0) | 553 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Scaling: mild (1) | 33 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Scaling: moderate (2) | 3 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Scaling: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Scaling: none (0) | 535 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Scaling: mild (1) | 46 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Scaling: moderate (2) | 3 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Scaling: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Scaling: none (0) | 487 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Scaling: mild (1) | 37 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Scaling: moderate (2) | 2 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Scaling: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Scaling: none (0) | 449 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Scaling: mild (1) | 35 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Scaling: moderate (2) | 3 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Scaling: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Scaling: none (0) | 398 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Scaling: mild (1) | 51 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Scaling: moderate (2) | 1 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Scaling: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Scaling: none (0) | 423 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Scaling: mild (1) | 25 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Scaling: moderate (2) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Scaling: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Scaling: none (0) | 462 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Scaling: mild (1) | 32 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Scaling: moderate (2) | 1 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Scaling: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Dryness: none (0) | 510 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Dryness: mild (1) | 73 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Dryness: moderate (2) | 6 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Dryness: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Dryness: none (0) | 496 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Dryness: mild (1) | 82 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Dryness: moderate (2) | 6 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Dryness: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Dryness: none (0) | 440 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Dryness: mild (1) | 82 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Dryness: moderate (2) | 4 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Dryness: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Dryness: none (0) | 398 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Dryness: mild (1) | 80 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Dryness: moderate (1) | 7 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Dryness: severe (3) | 2 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Dryness: none (0) | 382 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Dryness: mild (1) | 68 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Dryness: moderate (2) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Dryness: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Dryness: none (0) | 386 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Dryness: mild (1) | 61 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Dryness: moderate (2) | 1 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Dryness: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Dryness: none (0) | 422 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET Dryness: mild (1) | 70 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Dryness: moderate (2) | 2 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET Week 40/ET: Dryness: severe (3) | 1 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Pruritus: none (0) | 560 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Pruritus: mild (1) | 26 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Pruritus: moderate (2) | 3 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline: Pruritus: severe (3) Baseline: Pruritus: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Pruritus: none (0) | 540 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Pruritus: mild (1) | 40 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Pruritus: moderate (2) | 2 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Pruritus: severe (3) | 2 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Pruritus: none (0) | 481 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Pruritus: mild (2) | 40 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Pruritus: moderate (2) | 3 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Pruritus: severe (3) | 2 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Pruritus: none (0) | 454 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Pruritus: Week 24 mild (1) | 30 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Pruritus: moderate (2) | 2 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Pruritus: 24 severe (3) | 1 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Pruritus: none (0) | 429 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Pruritus: mild (1) | 18 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Pruritus: moderate (2) | 2 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Pruritus: severe (3) | 1 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Pruritus: none (0) | 418 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Pruritus: mild (1) | 29 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Pruritus: moderate (2) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Pruritus: severe (3) | 1 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Pruritus: none (0) | 457 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Pruritus: mild (1) | 34 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Pruritus: moderate (2) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Pruritus: severe (3) | 4 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline Burning/Stinging: none (0) | 536 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline Burning/Stinging: mild (1) | 53 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline Burning/Stinging: moderate (2) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Baseline Burning/Stinging: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Burning/Stinging: none (0) | 512 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Burning/Stinging: mild (1) | 65 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Burning/Stinging: moderate (2) | 7 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 4: Burning/Stinging: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Burning/Stinging: none (0) | 463 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Burning/Stinging: mild (1) | 56 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Burning/Stinging: moderate (2) | 7 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 12: Burning/Stinging: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Burning/Stinging: none (0) | 436 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Burning/Stinging: mild (1) | 50 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Burning/Stinging: moderate (2) | 1 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 24: Burning/Stinging: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Burning/Stinging: none (0) | 422 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Burning/Stinging: mild (1) | 25 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Burning/Stinging: moderate (2) | 3 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 36: Burning/Stinging: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Burning/Stinging: none (0) | 411 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Burning/Stinging: mild | 36 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Burning/Stinging: moderate (2) | 1 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40: Burning/Stinging: severe (3) | 0 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Burning/Stinging: none (0) | 451 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Burning/Stinging: mild (1) | 40 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Burning/Stinging: moderate (2) | 2 participants |
| SB204 Experienced | Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) | Week 40/ET: Burning/Stinging: severe (3) | 2 participants |