Trial Outcomes & Findings for Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination (NCT NCT04247074)

Last Updated: 2023-09-06

Results Overview

Investigator 4-point Photographic Scale of Glabellar Line Severity represents the severity of GL from none (grade 0), mild (grade 1), moderate (grade 2) to severe (grade 3). Each grade is depicted by an individual photograph and a descriptive text. The Investigators used the 4-point Photographic Scale for direct, live comparison with the subject's face at maximum frown. Subjects made their assessment of glabellar line severity independently of the Investigator's assessment. Subjects were asked to evaluate their GL at maximum frown by grading the GL severity from none (grade 0, smooth skin), mild (grade 1, fairly smooth skin), moderate (grade 2, frown lines) to severe (grade 3, deep frown lines).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

413 participants

Primary outcome timeframe

Month 1

Results posted on

2023-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	QM1114-DP in the LCL + Placebo in the GL QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection Botulinum toxin neuromodulator, QM1114-DP, will be injected into the LCL. Placebo, a buffered solution, will be injected the GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL and GL Placebo, a buffered solution. Mode of administration: intramuscular injection. Placebo will be injected into both the LCL and GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL + QM1114-DP in the GL QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Placebo, a buffered solution, will be injected into the LCL. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point	QM1114-DP in the LCL + GL QM1114-DP, a Botulinum Toxin Type A (BoNT-A). Mode of administration: intramuscular injection. Botulinum toxin neuromodulator: QM1114-DP will be injected into both the LCL and GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point
Overall Study STARTED	126	59	113	115
Overall Study COMPLETED	121	52	106	107
Overall Study NOT COMPLETED	5	7	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	QM1114-DP in the LCL + Placebo in the GL n=126 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the LCL. Placebo, a buffered solution, will be injected the GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL and GL n=59 Participants Placebo, a buffered solution. Mode of administration: intramuscular injection. Placebo will be injected into both the LCL and GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL + QM1114-DP in the GL n=113 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Placebo, a buffered solution, will be injected into the LCL. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point	QM1114-DP in the LCL + GL n=115 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A). Mode of administration: intramuscular injection. Botulinum toxin neuromodulator: QM1114-DP will be injected into both the LCL and GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point	Total n=413 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 10.44 • n=126 Participants	49.8 years STANDARD_DEVIATION 50.0 • n=59 Participants	50.4 years STANDARD_DEVIATION 9.77 • n=113 Participants	50.5 years STANDARD_DEVIATION 10.63 • n=115 Participants	50.3 years STANDARD_DEVIATION 10.2 • n=413 Participants
Sex: Female, Male Female	113 Participants n=126 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	55 Participants n=58 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	103 Participants n=113 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	97 Participants n=115 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	368 Participants n=412 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.
Sex: Female, Male Male	13 Participants n=126 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	3 Participants n=58 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	10 Participants n=113 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	18 Participants n=115 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	44 Participants n=412 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=126 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=58 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=113 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=115 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=412 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.
Race (NIH/OMB) Asian	1 Participants n=126 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=58 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	1 Participants n=113 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=115 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	2 Participants n=412 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=126 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	1 Participants n=58 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=113 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=115 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	1 Participants n=412 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.
Race (NIH/OMB) Black or African American	6 Participants n=126 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	2 Participants n=58 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	7 Participants n=113 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	6 Participants n=115 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	21 Participants n=412 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.
Race (NIH/OMB) White	115 Participants n=126 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	54 Participants n=58 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	105 Participants n=113 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	105 Participants n=115 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	379 Participants n=412 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.
Race (NIH/OMB) More than one race	1 Participants n=126 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=58 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=113 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	2 Participants n=115 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	3 Participants n=412 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=126 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	1 Participants n=58 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	0 Participants n=113 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	2 Participants n=115 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.	6 Participants n=412 Participants • We had one subject randomized to Placebo/Placebo group but they weren't treated (Subject was randomized in error and discontinued prior to receiving treatment.). Therefore, they are not included in the ITT or Safety populations.

PRIMARY outcome

Timeframe: Month 1

Population: Modified ITT population as actually randomized: All subjects ITT population who had an on-site Month 1 endpoint assessment conducted. The primary endpoint includes both LCL and GL analyses. The primary endpoint for GL success is dependent on results from 3 out of the 4 arms, which is provided. QM1114-DP in the LCL + Placebo analyses are presented in the next section as it is only relevant for the LCL endpoint success.

Outcome measures

Outcome measures
Measure	Placebo in the LCL and GL n=55 Participants Placebo, a buffered solution. Mode of administration: intramuscular injection. Placebo will be injected into both the LCL and GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL + QM1114-DP in the GL n=106 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Placebo, a buffered solution, will be injected into the LCL. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point	QM1114-DP in the LCL + GL (GL Data) n=108 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A). Mode of administration: intramuscular injection. Botulinum toxin neuromodulator: QM1114-DP will be injected into both the LCL and GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown	0 Participants	75 Participants	78 Participants

PRIMARY outcome

Timeframe: Month 1

Population: Modified intent-to-treat population as actually randomized: All subjects in intent-to-treat population who had an on-site Month 1 primary endpoint assessment conducted.

Investigator 4-point Photographic Scale of Lateral Canthal Line represents LCL severities from none (grade 0), mild (grade 1), moderate (grade 2), to severe (grade 3). Each grade is also depicted by an individual photograph and descriptive text. The Investigators used the LCL-ILA for direct, live comparison with the subject's face for grading LCL severity. Left and right LCL were assessed at maximum smile. Subject 4-point Photographic Scale of Lateral Canthal Line Severity represents LCL severities from Level 0, Level 1, Level 2, to Level 3. Each grade is also depicted by an individual photograph and descriptive text. Subjects made their assessments independently of the Investigator's assessment. Subjects evaluated their LCL severity (left and right side separately) at maximum smile.

Outcome measures

Outcome measures
Measure	Placebo in the LCL and GL n=117 Participants Placebo, a buffered solution. Mode of administration: intramuscular injection. Placebo will be injected into both the LCL and GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL + QM1114-DP in the GL n=55 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Placebo, a buffered solution, will be injected into the LCL. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point	QM1114-DP in the LCL + GL (GL Data) n=108 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A). Mode of administration: intramuscular injection. Botulinum toxin neuromodulator: QM1114-DP will be injected into both the LCL and GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile	53 Participants	0 Participants	59 Participants

SECONDARY outcome

Timeframe: Month 1

Population: Intent to treat population (all subjects randomized and administered study product) as actually randomized, excluding remote assessments. The secondary endpoint includes both LCL and GL analyses. QM1114-DP in the LCL + Placebo in the GL group analyses are presented in the next section. This is also applicable for the combination treatment (QM1114-DP in the LCL + GL) LCL outcome results.

Outcome measures

Outcome measures
Measure	Placebo in the LCL and GL n=51 Participants Placebo, a buffered solution. Mode of administration: intramuscular injection. Placebo will be injected into both the LCL and GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL + QM1114-DP in the GL n=103 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Placebo, a buffered solution, will be injected into the LCL. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point	QM1114-DP in the LCL + GL (GL Data) n=106 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A). Mode of administration: intramuscular injection. Botulinum toxin neuromodulator: QM1114-DP will be injected into both the LCL and GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown	1 Participants	97 Participants	102 Participants

SECONDARY outcome

Timeframe: Month 1

Population: Intent to treat population (all subjects randomized and administered study product) as actually randomized, excluding remote assessments.

Outcome measures

Outcome measures
Measure	Placebo in the LCL and GL n=113 Participants Placebo, a buffered solution. Mode of administration: intramuscular injection. Placebo will be injected into both the LCL and GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL + QM1114-DP in the GL n=51 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Placebo, a buffered solution, will be injected into the LCL. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point	QM1114-DP in the LCL + GL (GL Data) n=106 Participants QM1114-DP, a Botulinum Toxin Type A (BoNT-A). Mode of administration: intramuscular injection. Botulinum toxin neuromodulator: QM1114-DP will be injected into both the LCL and GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point
Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.	89 Participants	10 Participants	89 Participants

Adverse Events

QM1114-DP in the LCL + Placebo in the GL

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo in the LCL and GL

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo in the LCL + QM1114-DP in the GL

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

QM1114-DP in the LCL + GL

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	QM1114-DP in the LCL + Placebo in the GL n=123 participants at risk AEs are not collected separately for each type of treatment in each arm. QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the LCL. Placebo, a buffered solution, will be injected the GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL and GL n=58 participants at risk AEs are not collected separately for each type of treatment in each arm. Placebo, a buffered solution. Mode of administration: intramuscular injection. Placebo will be injected into both the LCL and GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL + QM1114-DP in the GL n=116 participants at risk AEs are not collected separately for each type of treatment in each arm. QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Placebo, a buffered solution, will be injected into the LCL. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point	QM1114-DP in the LCL + GL n=115 participants at risk AEs are not collected separately for each type of treatment in each arm. QM1114-DP, a Botulinum Toxin Type A (BoNT-A). Mode of administration: intramuscular injection. Botulinum toxin neuromodulator: QM1114-DP will be injected into both the LCL and GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/123 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/58 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/116 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.87% 1/115 • Number of events 1 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.
Infections and infestations Appendicitis	0.00% 0/123 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/58 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.86% 1/116 • Number of events 1 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/115 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.
Metabolism and nutrition disorders Dehydration	0.00% 0/123 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/58 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.86% 1/116 • Number of events 1 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/115 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.
Vascular disorders Hypertensive emergency	0.00% 0/123 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	1.7% 1/58 • Number of events 1 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/116 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/115 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.

Other adverse events

Other adverse events
Measure	QM1114-DP in the LCL + Placebo in the GL n=123 participants at risk AEs are not collected separately for each type of treatment in each arm. QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the LCL. Placebo, a buffered solution, will be injected the GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL and GL n=58 participants at risk AEs are not collected separately for each type of treatment in each arm. Placebo, a buffered solution. Mode of administration: intramuscular injection. Placebo will be injected into both the LCL and GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point Placebo GL dosage: 0.5 mL total, 0.1 mL per GL injection point	Placebo in the LCL + QM1114-DP in the GL n=116 participants at risk AEs are not collected separately for each type of treatment in each arm. QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo. Mode of administration: intramuscular injection. Placebo, a buffered solution, will be injected into the LCL. Botulinum toxin neuromodulator, QM1114-DP, will be injected into the GL. Placebo LCL dosage: 0.6 mL total, 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point	QM1114-DP in the LCL + GL n=115 participants at risk AEs are not collected separately for each type of treatment in each arm. QM1114-DP, a Botulinum Toxin Type A (BoNT-A). Mode of administration: intramuscular injection. Botulinum toxin neuromodulator: QM1114-DP will be injected into both the LCL and GL. QM1114-DP LCL dosage: 60 units, 0.6 mL total 0.1 mL per LCL injection point QM1114-DP GL dosage: 50 units, 0.5 mL total, 0.1 mL per GL injection point
Infections and infestations COVID-19	3.3% 4/123 • Number of events 4 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	6.9% 4/58 • Number of events 4 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	5.2% 6/116 • Number of events 6 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	2.6% 3/115 • Number of events 3 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.
Nervous system disorders Headache	2.4% 3/123 • Number of events 3 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/58 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	5.2% 6/116 • Number of events 6 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	3.5% 4/115 • Number of events 4 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.
Eye disorders Eyelid ptosis	0.00% 0/123 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/58 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	2.6% 3/116 • Number of events 3 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/115 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.
General disorders Injection site bruising	1.6% 2/123 • Number of events 2 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	1.7% 1/58 • Number of events 2 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	2.6% 3/116 • Number of events 3 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	1.7% 2/115 • Number of events 2 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.
General disorders Injection site pain	0.81% 1/123 • Number of events 1 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	3.4% 2/58 • Number of events 2 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/116 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.	0.00% 0/115 • 6 months 3 subjects had a randomization error which is why there is a difference in the Participant Flow (All Subjects Population) and the Adverse Events (Safety Population) Safety Population: All subjects who were administered the study product; subjects were analyzed according to as-treated principle.

Additional Information

Galderma Research & Development

Phone: 8179615000

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Principal investigator is a sponsor employee
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Restriction type: GT60