Trial Outcomes & Findings for Treatment of Moderate to Severe Glabellar Lines (NCT NCT04249583)
NCT ID: NCT04249583
Last Updated: 2023-06-18
Results Overview
The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
One Month
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 to be injected in the GL region
|
Placebo
A buffered solution; Mode of administration: intramuscular injection
Placebo: Placebo to be injected in the GL area
|
|---|---|---|
|
Overall Study
STARTED
|
225
|
75
|
|
Overall Study
COMPLETED
|
210
|
66
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Moderate to Severe Glabellar Lines
Baseline characteristics by cohort
| Measure |
Treatment
n=223 Participants
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
botulinum toxin: neuromodulator to be injected in the GL region
|
Placebo
n=74 Participants
A buffered solution; Mode of administration: intramuscular injection
Placebo: Placebo to be injected in the GL area
|
Total
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 12.41 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 11.19 • n=7 Participants
|
47.6 years
STANDARD_DEVIATION 12.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
203 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
185 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One MonthThe investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)
Outcome measures
| Measure |
Treatment
n=199 Participants
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
botulinum toxin: neuromodulator to be injected in the GL region
|
Placebo
n=67 Participants
A buffered solution; Mode of administration: intramuscular injection
Placebo: Placebo to be injected in the GL area
|
|---|---|---|
|
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
|
0 Participants
|
SECONDARY outcome
Timeframe: One MonthOutcome measures
| Measure |
Treatment
n=194 Participants
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
botulinum toxin: neuromodulator to be injected in the GL region
|
Placebo
n=64 Participants
A buffered solution; Mode of administration: intramuscular injection
Placebo: Placebo to be injected in the GL area
|
|---|---|---|
|
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown
|
187 Participants
|
3 Participants
|
Adverse Events
Treatment
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=222 participants at risk
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
botulinum toxin: neuromodulator to be injected in the GL region
|
Placebo
n=75 participants at risk
A buffered solution; Mode of administration: intramuscular injection
Placebo: Placebo to be injected in the GL area
|
|---|---|---|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.45%
1/222 • Number of events 1 • 6 months
|
0.00%
0/75 • 6 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.45%
1/222 • Number of events 1 • 6 months
|
0.00%
0/75 • 6 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.45%
1/222 • Number of events 1 • 6 months
|
0.00%
0/75 • 6 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/222 • 6 months
|
1.3%
1/75 • Number of events 1 • 6 months
|
|
Infections and infestations
Appendicitis
|
0.45%
1/222 • Number of events 1 • 6 months
|
0.00%
0/75 • 6 months
|
|
Infections and infestations
Cellulitis
|
0.45%
1/222 • Number of events 1 • 6 months
|
0.00%
0/75 • 6 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.45%
1/222 • Number of events 1 • 6 months
|
0.00%
0/75 • 6 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.45%
1/222 • Number of events 1 • 6 months
|
0.00%
0/75 • 6 months
|
Other adverse events
| Measure |
Treatment
n=222 participants at risk
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
botulinum toxin: neuromodulator to be injected in the GL region
|
Placebo
n=75 participants at risk
A buffered solution; Mode of administration: intramuscular injection
Placebo: Placebo to be injected in the GL area
|
|---|---|---|
|
Infections and infestations
COVID-19
|
1.4%
3/222 • Number of events 3 • 6 months
|
2.7%
2/75 • Number of events 2 • 6 months
|
|
Nervous system disorders
Headache
|
2.3%
5/222 • Number of events 5 • 6 months
|
0.00%
0/75 • 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