Trial Outcomes & Findings for Treatment of Moderate to Severe Lateral Canthal Lines (NCT NCT04249687)
NCT ID: NCT04249687
Last Updated: 2023-06-18
Results Overview
The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
303 participants
Primary outcome timeframe
Month 1
Results posted on
2023-06-18
Participant Flow
Participant milestones
| Measure |
Treatment
QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection
botulinum toxin: neuromodulator
|
Placebo
A buffered solution; Mode of administration: intramuscular injection
Placebo: placebo
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
73
|
|
Overall Study
COMPLETED
|
223
|
67
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Moderate to Severe Lateral Canthal Lines
Baseline characteristics by cohort
| Measure |
Treatment
n=230 Participants
QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection
botulinum toxin: neuromodulator
|
Placebo
n=73 Participants
A buffered solution; Mode of administration: intramuscular injection
Placebo: placebo
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 11.12 • n=99 Participants
|
48.2 years
STANDARD_DEVIATION 11.48 • n=107 Participants
|
50.1 years
STANDARD_DEVIATION 11.24 • n=206 Participants
|
|
Sex: Female, Male
Female
|
200 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
263 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
215 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
282 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 1The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe)
Outcome measures
| Measure |
Treatment
n=204 Participants
QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection
botulinum toxin: neuromodulator
|
Placebo
n=69 Participants
A buffered solution; Mode of administration: intramuscular injection
Placebo: placebo
|
|---|---|---|
|
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Line Investigator and Subject Assessments at Maximum Smile at One Month.
|
106 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: One MonthOutcome measures
| Measure |
Treatment
n=200 Participants
QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection
botulinum toxin: neuromodulator
|
Placebo
n=68 Participants
A buffered solution; Mode of administration: intramuscular injection
Placebo: placebo
|
|---|---|---|
|
Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.
|
175 Participants
|
8 Participants
|
Adverse Events
Treatment
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=230 participants at risk
QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection
botulinum toxin: neuromodulator
|
Placebo
n=73 participants at risk
A buffered solution; Mode of administration: intramuscular injection
Placebo: placebo
|
|---|---|---|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.43%
1/230 • Number of events 1 • 6 months
|
0.00%
0/73 • 6 months
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/230 • 6 months
|
1.4%
1/73 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.43%
1/230 • Number of events 1 • 6 months
|
0.00%
0/73 • 6 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.43%
1/230 • Number of events 1 • 6 months
|
0.00%
0/73 • 6 months
|
|
Vascular disorders
Hypertension
|
0.43%
1/230 • Number of events 1 • 6 months
|
0.00%
0/73 • 6 months
|
Other adverse events
| Measure |
Treatment
n=230 participants at risk
QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection
botulinum toxin: neuromodulator
|
Placebo
n=73 participants at risk
A buffered solution; Mode of administration: intramuscular injection
Placebo: placebo
|
|---|---|---|
|
Infections and infestations
COVID-19
|
2.6%
6/230 • Number of events 6 • 6 months
|
5.5%
4/73 • Number of events 4 • 6 months
|
|
Infections and infestations
Sinusitis
|
1.3%
3/230 • Number of events 3 • 6 months
|
2.7%
2/73 • Number of events 2 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/230 • 6 months
|
2.7%
2/73 • Number of events 2 • 6 months
|
|
General disorders
Injection site bruising
|
4.8%
11/230 • Number of events 12 • 6 months
|
4.1%
3/73 • Number of events 3 • 6 months
|
|
Nervous system disorders
Headache
|
0.43%
1/230 • Number of events 1 • 6 months
|
2.7%
2/73 • Number of events 2 • 6 months
|
Additional Information
Galderma Research & Development
Galderma Research & Development
Phone: 8179615000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60