Glabellar Frown Lines
Conditions
Brief summary
The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe GL.
Interventions
BIOLOGICALbotulinum toxin
neuromodulator to be injected in the GL region
BIOLOGICALPlacebo
Placebo to be injected in the GL area
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 18 years of age or older. 2. Moderate to severe GL at maximum frown as assessed by the Investigator. 3. Moderate to severe GL at maximum frown as assessed by the subject.
Exclusion criteria
1. Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment. 2. Female who is pregnant, breast feeding, or intends to conceive a child during the study. 3. Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP) or any botulinum toxin serotype.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month. | One Month | The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown | One Month |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
botulinum toxin: neuromodulator to be injected in the GL region | 223 |
| Placebo A buffered solution; Mode of administration: intramuscular injection
Placebo: Placebo to be injected in the GL area | 74 |
| Total | 297 |
Baseline characteristics
| Characteristic | Placebo | Total | Treatment |
|---|---|---|---|
| Age, Continuous | 47.6 years STANDARD_DEVIATION 11.19 | 47.6 years STANDARD_DEVIATION 12.1 | 47.6 years STANDARD_DEVIATION 12.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 24 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 11 Participants | 8 Participants |
| Race (NIH/OMB) White | 61 Participants | 246 Participants | 185 Participants |
| Sex: Female, Male Female | 65 Participants | 268 Participants | 203 Participants |
| Sex: Female, Male Male | 9 Participants | 29 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 222 | 0 / 75 |
| other Total, other adverse events | 8 / 222 | 2 / 75 |
| serious Total, serious adverse events | 5 / 222 | 1 / 75 |
Outcome results
Primary
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month.
The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)
Time frame: One Month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month. | 165 Participants |
| Placebo | Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month. | 0 Participants |
p-value: 0.05Cochran-Mantel-Haenszel
Secondary
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown
Time frame: One Month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown | 187 Participants |
| Placebo | Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown | 3 Participants |