Trial Outcomes & Findings for Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis) (NCT NCT03786770)
NCT ID: NCT03786770
Last Updated: 2023-02-16
Results Overview
Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Week 4 After FHL Treatment
Results posted on
2023-02-16
Participant Flow
Participant milestones
| Measure |
Cohort 1: DAXI 40 U GL / 12 U FHL
DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U
|
Cohort 2: DAXI 40 U GL / 18 U FHL
DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U
|
Cohort 3: DAXI 40 U GL / 24 U FHL
DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U
|
Cohort 4: DAXI 40 U GL / 30 U FHL
DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
16
|
16
|
|
Overall Study
COMPLETED
|
13
|
15
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)
Baseline characteristics by cohort
| Measure |
Cohort 1: DAXI 40 U GL / 12 U FHL
n=14 Participants
DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U
|
Cohort 2: DAXI 40 U GL / 18 U FHL
n=15 Participants
DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U
|
Cohort 3: DAXI 40 U GL / 24 U FHL
n=16 Participants
DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U
|
Cohort 4: DAXI 40 U GL / 30 U FHL
n=16 Participants
DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U
|
Total
n=61 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=157 Participants
|
0 Participants
n=390 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
60 Participants
n=390 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Age, Continuous
|
49 years
n=99 Participants
|
48.1 years
n=107 Participants
|
47.8 years
n=206 Participants
|
45.6 years
n=157 Participants
|
47.6 years
n=390 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
54 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
7 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
59 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
PRIMARY outcome
Timeframe: Week 4 After FHL TreatmentPopulation: The FHL-evaluable population
Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.
Outcome measures
| Measure |
Cohort 1: DAXI 40 U GL / 12 U FHL
n=14 Participants
DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U
|
Cohort 2: DAXI 40 U GL / 18 U FHL
n=15 Participants
DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U
|
Cohort 3: DAXI 40 U GL / 24 U FHL
n=16 Participants
DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U
|
Cohort 4: DAXI 40 U GL / 30 U FHL
n=15 Participants
DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U
|
|---|---|---|---|---|
|
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
|
85.7 percentage of subjects
|
86.7 percentage of subjects
|
93.8 percentage of subjects
|
100 percentage of subjects
|
Adverse Events
Cohort 1: DAXI 40 U GL / 12 U FHL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: DAXI 40 U GL / 18 U FHL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3: DAXI 40 U GL / 24 U FHL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4: DAXI 40 U GL / 30 U FHL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: DAXI 40 U GL / 12 U FHL
n=14 participants at risk
DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U.
|
Cohort 2: DAXI 40 U GL / 18 U FHL
n=15 participants at risk
DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U.
|
Cohort 3: DAXI 40 U GL / 24 U FHL
n=16 participants at risk
DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U.
|
Cohort 4: DAXI 40 U GL / 30 U FHL
n=16 participants at risk
DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U.
|
|---|---|---|---|---|
|
Eye disorders
Asthenopia
|
7.1%
1/14 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Eye disorders
Dry eye
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Eye disorders
Eyelid ptosis
|
7.1%
1/14 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
General disorders
Oedema
|
14.3%
2/14 • Number of events 2 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
26.7%
4/15 • Number of events 6 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 3 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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
Upper respiratory tract infection
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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
Gastroenteritis
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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
Tooth infection
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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
Wound infection
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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
|
7.1%
1/14 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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
Head discomfort
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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
Erythema
|
7.1%
1/14 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
26.7%
4/15 • Number of events 5 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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
Drug eruption
|
0.00%
0/14 • The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
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 FHL treatment (total of 38 weeks).
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
Additional Information
Domenico Vitarella, Sr. Director, Clinical Development
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