Trial Outcomes & Findings for Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines (NCT NCT03911102)
NCT ID: NCT03911102
Last Updated: 2023-06-27
Results Overview
Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Week 4 After LCL Treatment
Results posted on
2023-06-27
Participant Flow
Participant milestones
| Measure |
Cohort 1: DAXI 12 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 2: DAXI 24 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 3: DAXI 36 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 4: DAXI 48 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
15
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
Baseline characteristics by cohort
| Measure |
Cohort 1: DAXI 12 U
n=15 Participants
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 2: DAXI 24 U
n=17 Participants
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 3: DAXI 36 U
n=15 Participants
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 4: DAXI 48 U
n=16 Participants
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Age, Continuous
|
49.9 years
n=99 Participants
|
51.8 years
n=107 Participants
|
52.8 years
n=206 Participants
|
45.5 years
n=7 Participants
|
50 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
55 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
58 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 4 After LCL TreatmentPopulation: LCL Evaluable
Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale
Outcome measures
| Measure |
Cohort 1: DAXI 12 U
n=15 Participants
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 2: DAXI 24 U
n=17 Participants
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 3: DAXI 36 U
n=14 Participants
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 4: DAXI 48 U
n=16 Participants
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
|---|---|---|---|---|
|
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile
|
9 Participants
|
10 Participants
|
8 Participants
|
14 Participants
|
Adverse Events
Cohort 1: DAXI 12 U
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: DAXI 24 U
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3: DAXI 36 U
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 4: DAXI 48 U
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: DAXI 12 U
n=15 participants at risk
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 2: DAXI 24 U
n=17 participants at risk
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 3: DAXI 36 U
n=15 participants at risk
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 4: DAXI 48 U
n=16 participants at risk
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
|---|---|---|---|---|
|
Infections and infestations
Mastitis
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
Other adverse events
| Measure |
Cohort 1: DAXI 12 U
n=15 participants at risk
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 2: DAXI 24 U
n=17 participants at risk
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 3: DAXI 36 U
n=15 participants at risk
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
Cohort 4: DAXI 48 U
n=16 participants at risk
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Eye disorders
Eye pruritus
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
General disorders
Injection site bruising
|
20.0%
3/15 • Number of events 3 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
General disorders
Injection site erythema
|
20.0%
3/15 • Number of events 3 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
General disorders
Injection site oedema
|
20.0%
3/15 • Number of events 3 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
General disorders
Injection site pain
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
General disorders
Injury associated with device
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
17.6%
3/17 • Number of events 3 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
13.3%
2/15 • Number of events 2 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
12.5%
2/16 • Number of events 2 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Infections and infestations
Ear infection
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Infections and infestations
Localised infection
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Investigations
Blood glucose increased
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Investigations
Weight increased
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Investigations
White blood cell count increased
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
13.3%
2/15 • Number of events 2 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.7%
1/15 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/16 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/17 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/15 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
Additional Information
Todd Gross, PhD, VP, Clinical Development & Data Science
Revance Therapeutics, Inc.
Phone: 510-742-3400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study Center and/or Investigator shall submit to Revance a copy of the proposed publication at least sixty (60) days prior to the submission thereof for publication or disclosure to a third party: (i)to provide Revance with the opportunity to review and comment on the contents thereof, (ii)to identify any Confidential Information to be deleted from the proposed publication or disclosure, and (iii)or delay the publication or disclosure 90 days to allow Revance to pursue patent protections.
- Publication restrictions are in place
Restriction type: OTHER