Glabellar Frown Lines
Conditions
Brief summary
An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.
Detailed description
Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.
Interventions
BIOLOGICALAbobotulinumtoxinA
AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Moderate to Severe Glabellar Lines at Maximum Frown * Understands study requirements and signs an informed consent
Exclusion criteria
* Known allergy to any component of study product * Pregnant or breast feeding or intending to get pregnant during the study * Botulinum toxin treatment in the face within 9 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines | 12 months | Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows | Months 1,3,6,7,9 and 12 | FACE-Q Appraisal of Lines: Between Eyebrows. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome. |
| Evaluate the Impact of Treatment; Psychological Function | Months 1,3,6,7,9 and 12 | FACE-Q Psychological Function. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome. |
| Subject Satisfaction With Aesthetic Outcome in Treated Area | Months 1,3,6,7,9 and 12 | based on Subject Satisfaction questionnaire data |
| Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Months 1,3,6,7,9 and 12 | Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown. |
| Onset of Treatment Response | After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit | Subject perception of treatment response |
| Subject Self-Assessment Using a 4-point Categorical Scale | Months 1,3,6,7,9 and 12 | Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AbobotulinumtoxinA Open-label
AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | AbobotulinumtoxinA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 107 Participants |
| Region of Enrollment United States | 120 Participants |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 12 Participants |
| Toxin Naive Status Non-toxin Naive | 81 Participants |
| Toxin Naive Status Toxin Naive | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 2 / 120 |
Outcome results
Primary
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines
Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.
Time frame: 12 months
Population: Modified Intent to Treat Population (all subjects treated with study product both at Baseline and Month 6) attending Month 12 visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AbobotulinumtoxinA | Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines | Highly satisfied | 66 Participants |
| AbobotulinumtoxinA | Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines | Satisfied | 38 Participants |
| AbobotulinumtoxinA | Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines | Dissatisfied | 4 Participants |
| AbobotulinumtoxinA | Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines | Highly dissatisfied | 2 Participants |
Secondary
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows
FACE-Q Appraisal of Lines: Between Eyebrows. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.
Time frame: Months 1,3,6,7,9 and 12
Population: Intent to Treat Population (all subjects treated with study product) attending visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AbobotulinumtoxinA | Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows | Baseline | 31.6 score on a scale | Standard Deviation 18.22 |
| AbobotulinumtoxinA | Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows | Month 1 | 83.3 score on a scale | Standard Deviation 19.22 |
| AbobotulinumtoxinA | Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows | Month 3 | 64.2 score on a scale | Standard Deviation 22.46 |
| AbobotulinumtoxinA | Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows | Month 6 | 44.7 score on a scale | Standard Deviation 20.78 |
| AbobotulinumtoxinA | Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows | Month 7 | 85.5 score on a scale | Standard Deviation 17.77 |
| AbobotulinumtoxinA | Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows | Month 9 | 70.7 score on a scale | Standard Deviation 23.23 |
| AbobotulinumtoxinA | Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows | Month 12 | 51.5 score on a scale | Standard Deviation 22.18 |
Secondary
Evaluate the Impact of Treatment; Psychological Function
FACE-Q Psychological Function. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.
Time frame: Months 1,3,6,7,9 and 12
Population: Intent to Treat Population (all subjects treated with study product) attending visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AbobotulinumtoxinA | Evaluate the Impact of Treatment; Psychological Function | Month 7 | 85.1 score on a scale | Standard Deviation 17.6 |
| AbobotulinumtoxinA | Evaluate the Impact of Treatment; Psychological Function | Baseline | 72.2 score on a scale | Standard Deviation 22.56 |
| AbobotulinumtoxinA | Evaluate the Impact of Treatment; Psychological Function | Month 1 | 84.0 score on a scale | Standard Deviation 15.94 |
| AbobotulinumtoxinA | Evaluate the Impact of Treatment; Psychological Function | Month 3 | 81.6 score on a scale | Standard Deviation 17.29 |
| AbobotulinumtoxinA | Evaluate the Impact of Treatment; Psychological Function | Month 6 | 78.0 score on a scale | Standard Deviation 20.35 |
| AbobotulinumtoxinA | Evaluate the Impact of Treatment; Psychological Function | Month 9 | 82.7 score on a scale | Standard Deviation 19.02 |
| AbobotulinumtoxinA | Evaluate the Impact of Treatment; Psychological Function | Month 12 | 79.0 score on a scale | Standard Deviation 17.46 |
Secondary
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity
Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown.
Time frame: Months 1,3,6,7,9 and 12
Population: Intent to Treat Population (all subjects treated with study product) attending visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 12 | Mild | 16 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Baseline | Severe | 82 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Baseline | Moderate | 38 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Baseline | Mild | 0 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Baseline | None | 0 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 1 | Severe | 0 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 1 | Moderate | 2 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 1 | Mild | 24 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 1 | None | 91 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 3 | Severe | 8 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 3 | Moderate | 27 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 3 | Mild | 57 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 3 | None | 23 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 6 | Severe | 50 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 6 | Moderate | 47 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 6 | Mild | 16 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 6 | None | 0 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 7 | Severe | 0 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 7 | Moderate | 3 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 7 | Mild | 22 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 7 | None | 81 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 9 | Severe | 2 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 9 | Moderate | 30 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 9 | Mild | 45 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 9 | None | 34 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 12 | Severe | 35 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 12 | Moderate | 57 Participants |
| AbobotulinumtoxinA | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Month 12 | None | 2 Participants |
Secondary
Onset of Treatment Response
Subject perception of treatment response
Time frame: After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit
Population: Intent to Treat Population (all subjects treated with study product) who returned diary cards.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AbobotulinumtoxinA | Onset of Treatment Response | Following Baseline Treatment | 2.5 days | Standard Error 0.14 |
| AbobotulinumtoxinA | Onset of Treatment Response | Following Month 6 Treatment | 2.4 days | Standard Error 0.12 |
Secondary
Subject Satisfaction With Aesthetic Outcome in Treated Area
based on Subject Satisfaction questionnaire data
Time frame: Months 1,3,6,7,9 and 12
Population: Intent to Treat population (all subjects treated with study product). Number analyzed = Number of subjects completing Subject Satisfaction questionnaire at each visit following treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 9 | Very satisfied | 61 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 9 | Satisfied | 40 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 9 | Dissatisfied | 8 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 1 | Very satisfied | 83 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 1 | Satisfied | 32 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 1 | Dissatisfied | 2 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 1 | Very dissatisfied | 0 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 3 | Very satisfied | 44 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 3 | Satisfied | 55 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 3 | Dissatisfied | 14 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 3 | Very dissatisfied | 2 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 6 | Very satisfied | 35 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 6 | Satisfied | 50 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 6 | Dissatisfied | 23 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 6 | Very dissatisfied | 5 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 7 | Very satisfied | 78 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 7 | Satisfied | 26 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 7 | Dissatisfied | 2 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 7 | Very dissatisfied | 0 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 9 | Very dissatisfied | 2 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 12 | Very satisfied | 43 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 12 | Satisfied | 49 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 12 | Dissatisfied | 16 Participants |
| AbobotulinumtoxinA | Subject Satisfaction With Aesthetic Outcome in Treated Area | Month 12 | Very dissatisfied | 2 Participants |
Secondary
Subject Self-Assessment Using a 4-point Categorical Scale
Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown
Time frame: Months 1,3,6,7,9 and 12
Population: Intent to Treat Population (all subjects treated with study product) attending visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 1 | Severe | 0 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Baseline | Severe | 78 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Baseline | Moderate | 42 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Baseline | Mild | 0 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Baseline | None | 0 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 1 | Moderate | 10 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 1 | Mild | 54 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 1 | None | 53 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 3 | Severe | 12 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 3 | Moderate | 50 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 3 | Mild | 45 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 3 | None | 8 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 6 | Severe | 55 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 6 | Moderate | 48 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 6 | Mild | 10 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 6 | None | 0 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 7 | Severe | 0 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 7 | Moderate | 14 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 7 | Mild | 36 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 7 | None | 56 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 9 | Severe | 9 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 9 | Moderate | 31 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 9 | Mild | 53 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 9 | None | 18 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 12 | Severe | 34 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 12 | Moderate | 57 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 12 | Mild | 19 Participants |
| AbobotulinumtoxinA | Subject Self-Assessment Using a 4-point Categorical Scale | Month 12 | None | 0 Participants |