Glabellar Frown Lines (GL), Lateral Canthal Lines (LCL)
Conditions
Brief summary
This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.
Interventions
BIOLOGICALbotulinum toxin neuromodulator
QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL
BIOLOGICALPlacebo
Placebo will be injected into either the LCL, GL, or both the LCL and GL
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 18 years of age or older. 2. Moderate to severe LCL at maximum smile as assessed by the Investigator. 3. Moderate to severe LCL at maximum smile as assessed by the subject. 4. Moderate to severe GL at maximum frown as assessed by the Investigator. 5. Moderate to severe GL at maximum frown as assessed by the subject
Exclusion criteria
1. Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment. 2. Female who is pregnant, breast feeding, or intends to conceive a child during the study. 3. Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown | Month 1 | 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). |
| Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile | Month 1 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown | Month 1 |
| Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile. | Month 1 |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 126 |
| 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 | 59 |
| 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 | 113 |
| 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 | 115 |
| Total | 413 |
Baseline characteristics
| Characteristic | QM1114-DP in the LCL + Placebo in the GL | Total | QM1114-DP in the LCL + GL | Placebo in the LCL + QM1114-DP in the GL | Placebo in the LCL and GL |
|---|---|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 10.44 | 50.3 years STANDARD_DEVIATION 10.2 | 50.5 years STANDARD_DEVIATION 10.63 | 50.4 years STANDARD_DEVIATION 9.77 | 49.8 years STANDARD_DEVIATION 50 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 21 Participants | 6 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 115 Participants | 379 Participants | 105 Participants | 105 Participants | 54 Participants |
| Sex: Female, Male Female | 113 Participants | 368 Participants | 97 Participants | 103 Participants | 55 Participants |
| Sex: Female, Male Male | 13 Participants | 44 Participants | 18 Participants | 10 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 123 | 0 / 58 | 0 / 116 | 0 / 115 |
| other Total, other adverse events | 9 / 123 | 6 / 58 | 18 / 116 | 9 / 115 |
| serious Total, serious adverse events | 0 / 123 | 1 / 58 | 1 / 116 | 1 / 115 |
Outcome results
Primary
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown
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).
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo in the LCL and GL | Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown | 0 Participants |
| Placebo in the LCL + QM1114-DP in the GL | Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown | 75 Participants |
| QM1114-DP in the LCL + GL (GL Data) | Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown | 78 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
Primary
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo in the LCL and GL | Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile | 53 Participants |
| Placebo in the LCL + QM1114-DP in the GL | Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile | 0 Participants |
| QM1114-DP in the LCL + GL (GL Data) | Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile | 59 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.
Time frame: Month 1
Population: Intent to treat population (all subjects randomized and administered study product) as actually randomized, excluding remote assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo in the LCL and GL | Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile. | 89 Participants |
| Placebo in the LCL + QM1114-DP in the GL | Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile. | 10 Participants |
| QM1114-DP in the LCL + GL (GL Data) | Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile. | 89 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo in the LCL and GL | Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown | 1 Participants |
| Placebo in the LCL + QM1114-DP in the GL | Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown | 97 Participants |
| QM1114-DP in the LCL + GL (GL Data) | Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown | 102 Participants |
p-value: <0.001Cochran-Mantel-Haenszel