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The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe LCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection |
|
| Placebo | Placebo Comparator | A buffered solution; Mode of administration: intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin | Biological | neuromodulator |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Line Investigator and Subject Assessments at Maximum Smile at One Month. | The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe) | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile. | One Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ablon Skin Institute and Research Center | Manhattan Beach | California | 90266 | United States | ||
| Dermatology Cosmetic Laser Medical Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection botulinum toxin: neuromodulator |
| FG001 | Placebo | A buffered solution; Mode of administration: intramuscular injection Placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection botulinum toxin: neuromodulator |
| BG001 | Placebo | A buffered solution; Mode of administration: intramuscular injection Placebo: placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Lateral Canthal Line Investigator and Subject Assessments at Maximum Smile at One Month. | The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe) | Posted | Count of Participants | Participants | Month 1 |
|
6 months
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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 | Treatment | QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection botulinum toxin: neuromodulator |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galderma Research & Development | Galderma Research & Development | 8179615000 | clinical.studies@galderma.com |
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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 10, 2020 | May 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2021 | May 23, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Placebo | Biological | placebo |
|
| San Diego |
| California |
| 92121 |
| United States |
| Art of Skin, MD | Solana Beach | California | 92075 | United States |
| Siperstein Dermatology Group, PLLC | Boynton Beach | Florida | 33472 | United States |
| Facial Plastic Surgicenter, Ltd | Baltimore | Maryland | 21208 | United States |
| The Center for Dermatology, Cosmetic & Laser Surgery | Mount Kisco | New York | 10549 | United States |
| Rochester Dermatologic Surgery, Ltd | Victor | New York | 14564 | United States |
| Aesthetic Solutions, PA | Chapel Hill | North Carolina | 27517 | United States |
| Dr. Shannon Humphrey, Inc | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Pacific Dermaesthetics, Inc | Vancouver | British Columbia | V6H-4E1 | Canada |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile. | Posted | Count of Participants | Participants | One Month |
|
|
|
|
| 0 |
| 230 |
| 3 |
| 230 |
| 20 |
| 230 |
| EG001 | Placebo | A buffered solution; Mode of administration: intramuscular injection Placebo: placebo | 0 | 73 | 1 | 73 | 12 | 73 |
| Clavicle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Injection site bruising | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
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| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |