Glabellar Lines, Lateral Canthal Lines
Conditions
Brief summary
This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal Lines (Crow's Feet and LCL).
Interventions
BIOLOGICALbotulinum toxin neuromodulator
A dose of QM1114-DP will be injected in the GL area and in the LCL area.
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Male or female at least 18 years of age.
Exclusion criteria
* Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment. * Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product). * Female who is pregnant, breast feeding, or intends to conceive a child during the study. * 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 Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown | Week 4 | 4-point scale |
| Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile | Week 4 | 4-point scale |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| QM1114-DP in the LCL and the GL Areas The investigational product (QM1114-DP) is a BoNT Type A.
At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines.
botulinum toxin neuromodulator: A dose of QM1114-DP will be injected in the GL area and in the LCL area. | 902 |
| Total | 902 |
Baseline characteristics
| Characteristic | QM1114-DP in the LCL and the GL Areas |
|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 11.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants |
| Race (NIH/OMB) White | 820 Participants |
| Region of Enrollment United States | 902 participants |
| Sex: Female, Male Female | 775 Participants |
| Sex: Female, Male Male | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 902 |
| other Total, other adverse events | 243 / 902 |
| serious Total, serious adverse events | 23 / 902 |
Outcome results
Primary
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown
4-point scale
Time frame: Week 4
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QM1114-DP in the GL | Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown | 769 Participants |
Primary
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile
4-point scale
Time frame: Week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QM1114-DP in the GL | Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile | 719 Participants |