Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination

Conditions
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Glabellar Frown Lines (GL), Lateral Canthal Lines (LCL)

Intervention / Treatment
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* Biological: botulinum toxin neuromodulator
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or older. Moderate to severe LCL at maximum smile as assessed by the Investigator. Moderate to severe LCL at maximum smile as assessed by the subject. Moderate to severe GL at maximum frown as assessed by the Investigator. Moderate to severe GL at maximum frown as assessed by the subject Exclusion Criteria: Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment. Female who is pregnant, breast feeding, or intends to conceive a child during the study. Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QM1114-DP in the LCL + Placebo in the GL<br>QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection | Biological: botulinum toxin neuromodulator<br>* QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL<br>* Other names: QM1114-DP;Biological: Placebo<br>* Placebo will be injected into either the LCL, GL, or both the LCL and GL<br>|
| Placebo Comparator: Placebo in the LCL and GL<br>A buffered solution; Mode of administration: intramuscular injection | Biological: Placebo<br>* Placebo will be injected into either the LCL, GL, or both the LCL and GL<br>|
| Experimental: Placebo in the LCL + QM1114-DP in the GL<br>QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection | Biological: botulinum toxin neuromodulator<br>* QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL<br>* Other names: QM1114-DP;Biological: Placebo<br>* Placebo will be injected into either the LCL, GL, or both the LCL and GL<br>|
| Experimental: QM1114-DP in the LCL + GL<br>QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection | Biological: botulinum toxin neuromodulator<br>* QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL<br>* Other names: QM1114-DP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Month 1 | 
| 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. | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |