Glabellar Frown Lines
Conditions
Brief summary
An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines
Interventions
BIOLOGICALAbobotulinumtoxinA dose 4
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
BIOLOGICALAbobotulinumtoxinA dose level 1 or 2
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
OTHERplacebo
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
BIOLOGICALAbobotulinumtoxinA dose 3
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale * Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale
Exclusion criteria
* Botulinum toxin treatment in the face within 9 months prior to study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Composite Responders at Month 1 | Month 1 after treatment | composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA) |
Countries
United States
Participant flow
Pre-assignment details
401 subjects were randomized, and 399 subjects received study product. Two (2) of the 401 randomized subjects did not receive study product due to hypertension that was identified pre-treatment.
Participants by arm
| Arm | Count |
|---|---|
| Dose Level 1 AbobotulinumtoxinA Subjects randomized (4:1) to dose level 1 AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines | 80 |
| Dose Level 2 AbobotulinumtoxinA Subjects randomized (4:1) to dose level 2 AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines | 80 |
| Dose Level 3 AbobotulinumtoxinA Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 3: treatment of glabellar facial lines | 80 |
| Dose Level 4 AbobotulinumtoxinA Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 4: treatment of glabellar facial lines | 81 |
| Placebo Subjects randomized to placebo | 78 |
| Total | 399 |
Baseline characteristics
| Characteristic | Dose Level 1 AbobotulinumtoxinA | Total | Placebo | Dose Level 4 AbobotulinumtoxinA | Dose Level 3 AbobotulinumtoxinA | Dose Level 2 AbobotulinumtoxinA |
|---|---|---|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 9.54 | 48.4 years STANDARD_DEVIATION 10.68 | 47.6 years STANDARD_DEVIATION 11.5 | 48.4 years STANDARD_DEVIATION 10.22 | 46.3 years STANDARD_DEVIATION 11.52 | 50.2 years STANDARD_DEVIATION 10.33 |
| Fitzpatrick Skin Type (FST) FST I | 1 Participants | 7 Participants | 5 Participants | 0 Participants | 1 Participants | 0 Participants |
| Fitzpatrick Skin Type (FST) FST II | 27 Participants | 106 Participants | 17 Participants | 20 Participants | 21 Participants | 21 Participants |
| Fitzpatrick Skin Type (FST) FST III | 32 Participants | 154 Participants | 33 Participants | 28 Participants | 28 Participants | 33 Participants |
| Fitzpatrick Skin Type (FST) FST IV | 14 Participants | 85 Participants | 19 Participants | 19 Participants | 21 Participants | 12 Participants |
| Fitzpatrick Skin Type (FST) FST V | 4 Participants | 24 Participants | 0 Participants | 8 Participants | 4 Participants | 8 Participants |
| Fitzpatrick Skin Type (FST) FST VI | 2 Participants | 23 Participants | 4 Participants | 6 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 8 Participants | 1 Participants | 5 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 26 Participants | 4 Participants | 6 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 9 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 72 Participants | 348 Participants | 71 Participants | 66 Participants | 72 Participants | 67 Participants |
| Region of Enrollment United States | 80 participants | 399 participants | 78 participants | 81 participants | 80 participants | 80 participants |
| Sex: Female, Male Female | 72 Participants | 352 Participants | 68 Participants | 73 Participants | 68 Participants | 71 Participants |
| Sex: Female, Male Male | 8 Participants | 47 Participants | 10 Participants | 8 Participants | 12 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 | 0 / 80 | 0 / 81 | 0 / 78 |
| other Total, other adverse events | 3 / 80 | 1 / 80 | 1 / 80 | 4 / 81 | 2 / 78 |
| serious Total, serious adverse events | 1 / 80 | 3 / 80 | 0 / 80 | 1 / 81 | 0 / 78 |
Outcome results
Primary
Number of Composite Responders at Month 1
composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
Time frame: Month 1 after treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Level 1 AbobotulinumtoxinA | Number of Composite Responders at Month 1 | 64 Participants |
| Dose Level 2 AbobotulinumtoxinA | Number of Composite Responders at Month 1 | 71 Participants |
| Dose Level 3 AbobotulinumtoxinA | Number of Composite Responders at Month 1 | 72 Participants |
| Dose Level 4 AbobotulinumtoxinA | Number of Composite Responders at Month 1 | 77 Participants |
| Placebo | Number of Composite Responders at Month 1 | 2 Participants |