Trial Outcomes & Findings for Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines (NCT NCT04225260)
NCT ID: NCT04225260
Last Updated: 2023-06-18
Results Overview
4-point scale
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
902 participants
Primary outcome timeframe
Week 4
Results posted on
2023-06-18
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
902
|
|
Overall Study
COMPLETED
|
790
|
|
Overall Study
NOT COMPLETED
|
112
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
Baseline characteristics by cohort
| Measure |
QM1114-DP in the LCL and the GL Areas
n=902 Participants
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.
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|---|---|
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Age, Continuous
|
47.2 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
775 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
820 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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902 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 4Population: FAS
4-point scale
Outcome measures
| Measure |
QM1114-DP in the GL
n=847 Participants
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.
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|---|---|
|
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown
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769 Participants
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PRIMARY outcome
Timeframe: Week 44-point scale
Outcome measures
| Measure |
QM1114-DP in the GL
n=847 Participants
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.
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|---|---|
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Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile
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719 Participants
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Adverse Events
QM1114-DP in the LCL and the GL Areas
Serious events: 23 serious events
Other events: 243 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
QM1114-DP in the LCL and the GL Areas
n=902 participants at risk
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.
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|---|---|
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Infections and infestations
Appendicitis
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0.11%
1/902 • Number of events 1 • 12 months
|
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Infections and infestations
COVID-19
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Infections and infestations
Cholecystitis infective
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Infections and infestations
Post procedural infection
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Infections and infestations
Urosepsis
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0.11%
1/902 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
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0.11%
1/902 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastric ulcer
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0.11%
1/902 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adnocarcinoma of colon
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Nervous system disorders
Presyncope
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Endocrine disorders
Goitre
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Suicide
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.11%
1/902 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypertensive urgency
|
0.11%
1/902 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
QM1114-DP in the LCL and the GL Areas
n=902 participants at risk
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.
|
|---|---|
|
General disorders
Injection site Pain
|
7.2%
65/902 • Number of events 145 • 12 months
|
|
General disorders
Injection site bruising
|
6.5%
59/902 • Number of events 71 • 12 months
|
|
Infections and infestations
COVID-19
|
5.3%
48/902 • Number of events 49 • 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
15/902 • Number of events 15 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
1.7%
15/902 • Number of events 16 • 12 months
|
|
Infections and infestations
Sinusitis
|
1.00%
9/902 • Number of events 10 • 12 months
|
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Nervous system disorders
Headache
|
6.0%
54/902 • Number of events 56 • 12 months
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
16/902 • Number of events 16 • 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
15/902 • Number of events 15 • 12 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
10/902 • Number of events 10 • 12 months
|
|
Vascular disorders
Hypertension
|
2.1%
19/902 • Number of events 19 • 12 months
|
Additional Information
Galderma Research & Development
Galderma Research & Development
Phone: 817-961-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60