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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 GL.
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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 to be injected in the GL region |
|
| 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 at One Month. | The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe) | One Month |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown | 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 | ||
| Moradi MD |
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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 to be injected in the GL region |
| FG001 | Placebo | A buffered solution; Mode of administration: intramuscular injection Placebo: Placebo to be injected in the GL area |
| 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 to be injected in the GL region |
| BG001 | 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 Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month. | The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe) | Posted | Count of Participants | Participants | One Month |
|
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 to be injected in the GL region |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcoholic pancreatitis | 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 to be injected in the GL area |
|
| Vista |
| California |
| 92083 |
| United States |
| Etre Cosmetic Dermatology and Laser Center | New Orleans | Louisiana | 70130 | United States |
| Maryland Dermatology, Laser Skin & Vein | Hunt Valley | Maryland | 21030 | United States |
| Skin Specialist, PC | Omaha | Nebraska | 68144 | United States |
| Robert Schwarcz, MD, PC | New York | New York | 10021 | United States |
| Sachin M Shridharani, MD | New York | New York | 10021 | United States |
| Wilmington Dermatology Center, PLLC | Wilmington | North Carolina | 28405 | United States |
| The Practice of Brian S Biesman, MD | Nashville | Tennessee | 37203 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Dallas Center for Dermatology & Aesthetics | Dallas | Texas | 75225 | United States |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | United States |
| Integrated Aesthetics, Inc | Spring | Texas | 77388 | United States |
| Sweat Clinics of Canada | Toronto | Ontario | M5R 3N8 | Canada |
A buffered solution; Mode of administration: intramuscular injection
Placebo: Placebo to be injected in the GL area
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown | Posted | Count of Participants | Participants | One Month |
|
|
|
| 0 |
| 222 |
| 5 |
| 222 |
| 8 |
| 222 |
| EG001 | Placebo | A buffered solution; Mode of administration: intramuscular injection Placebo: Placebo to be injected in the GL area | 0 | 75 | 1 | 75 | 2 | 75 |
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Appendicitis | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system 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 |