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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QM1114-DP in the LCL + Placebo in the GL | Experimental | QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection |
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| Placebo in the LCL and GL | Placebo Comparator | A buffered solution; Mode of administration: intramuscular injection |
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| Placebo in the LCL + QM1114-DP in the GL | Experimental | QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection |
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| QM1114-DP in the LCL + GL | Experimental | QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin neuromodulator | Biological | QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Testing of Beverly Hills | Encino | California | 91436 | United States | ||
| Ava MD |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2020 | May 23, 2023 |
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| Placebo | Biological | Placebo will be injected into either the LCL, GL, or both the LCL and GL |
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| Santa Monica |
| California |
| 90404 |
| United States |
| Skin Care & Laser Physicians of Beverly Hills | West Hollywood | California | 90069 | United States |
| Center for Clinical and Cosmetic Research | Aventura | Florida | 33180 | United States |
| Baumann Cosmetic & Research Institute, Inc | Miami | Florida | 33137 | United States |
| Washington Institute of Dermatologic Laser Surgery | Chevy Chase | Maryland | 20815 | United States |
| Maryland Dermatology, Laser, Skin & Vein Institute | Hunt Valley | Maryland | 21030 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Lorenc Aesthetic Plastic Surgery Center | New York | New York | 10028 | United States |
| Elite Aesthetic Research | Cincinnati | Ohio | 45236 | United States |
| The Westlake Dermatology Clinical Research | Austin | Texas | 78746 | United States |
| Bertucci Medspa, Inc | Woodbridge | Ontario | L4L 8E2 | Canada |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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. | Count of Participants | Participants |
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| Race (NIH/OMB) | 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. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Count of Participants | Participants | Month 1 |
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| 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. | 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. | Posted | Count of Participants | Participants | Month 1 |
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| Secondary | Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown | 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. | Posted | Count of Participants | Participants | Month 1 |
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| Secondary | Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile. | Intent to treat population (all subjects randomized and administered study product) as actually randomized, excluding remote assessments. | Posted | Count of Participants | Participants | Month 1 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QM1114-DP in the LCL + Placebo in the GL | 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 | 0 | 123 | 0 | 123 | 9 | 123 |
| EG001 | Placebo in the LCL and GL | 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 | 0 | 58 | 1 | 58 | 6 | 58 |
| EG002 | Placebo in the LCL + QM1114-DP in the GL | 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 | 0 | 116 | 1 | 116 | 18 | 116 |
| EG003 | QM1114-DP in the LCL + GL | 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 | 0 | 115 | 1 | 115 | 9 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enterocutaneous fistula | Gastrointestinal disorders | Systematic Assessment |
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| Appendicitis | Infections and infestations | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertensive emergency | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Eyelid ptosis | Eye disorders | Systematic Assessment |
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| Injection site bruising | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galderma Research & Development | Galderma Research & Development | 8179615000 | clinical.studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2021 | May 23, 2023 | SAP_001.pdf |
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| OG001 |
| 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 |
| OG002 | QM1114-DP in the LCL + GL (LCL Data) | 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 |
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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 |
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