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This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal Lines (Crow's Feet and LCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QM1114-DP in the LCL and the GL areas | Experimental | The investigational product (QM1114-DP) is a BoNT Type A. At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin neuromodulator | Biological | A dose of QM1114-DP will be injected in the GL area and in the LCL area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown | 4-point scale | Week 4 |
| Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile | 4-point scale | Week 4 |
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Inclusion Criteria:
- Male or female at least 18 years of age.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | United States | ||
| Investigate MD, LLC. |
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| ID | Title | Description |
|---|---|---|
| FG000 | QM1114-DP in the LCL and the GL Areas | The investigational product (QM1114-DP) is a BoNT Type A. At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines. botulinum toxin neuromodulator: A dose of QM1114-DP will be injected in the GL area and in the LCL area. |
| 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 | Aug 26, 2020 | May 23, 2023 |
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| Scottsdale |
| Arizona |
| 85255 |
| United States |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| Rejuva Medical Aesthetics, LLC | Los Angeles | California | 90025 | United States |
| Westside Aesthetics | Los Angeles | California | 90025 | United States |
| Marcus Facial Plastic Surgery | Redondo Beach | California | 90277 | United States |
| The Maas Clinic Research Center | San Francisco | California | 94115 | United States |
| ArteMedica | Santa Rosa | California | 95401 | United States |
| AboutSkin Research, LLC | Greenwood Village | Colorado | 80111 | United States |
| Modern Dermatology PC | Westport | Connecticut | 06880 | United States |
| Center for Clinical and Cosmetic Research | Aventura | Florida | 33180 | United States |
| Steven Fagien, MD, PA | Boca Raton | Florida | 33431 | United States |
| Susan H. Weinkle, M.D | Bradenton | Florida | 34209 | United States |
| Miami Skin and Vein LLC | Coral Gables | Florida | 33134 | United States |
| Mayoral Dermatology | Coral Gables | Florida | 33143 | United States |
| Skin Research Institute, LLC | Coral Gables | Florida | 33146 | United States |
| Research Institute of SouthEast, LLC | West Palm Beach | Florida | 33401 | United States |
| Hamilton Research LLC | Alpharetta | Georgia | 30022 | United States |
| Chicago Cosmetic Surgery and Dermatology, Inc | Chicago | Illinois | 60654 | United States |
| Pure Dermatology, LLC | Metairie | Louisiana | 70001 | United States |
| SkinCare Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
| Skin Laser and Surgery Specialist of NY/NJ | Hackensack | New Jersey | 07601 | United States |
| Elite Aesthetic Research | Cincinnati | Ohio | 45236 | United States |
| Aventiv Research, Inc. | Dublin | Ohio | 43016 | United States |
| Dallas Plastic Surgery Institute | Dallas | Texas | 75231 | United States |
| Center for Advanced Clinical Research | Dallas | Texas | 75254 | United States |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | United States |
| SkinDC, PLLC | Arlington | Virginia | 22209 | United States |
| EthiQ2 Research, LLC | Mequon | Wisconsin | 53092 | United States |
| Jose Raul Montes Eyes & Facial Rejuvenation LLC | San Juan | 00917 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | QM1114-DP in the LCL and the GL Areas | The investigational product (QM1114-DP) is a BoNT Type A. At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines. botulinum toxin neuromodulator: A dose of QM1114-DP will be injected in the GL area and in the LCL area. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown | 4-point scale | FAS | Posted | Count of Participants | Participants | Week 4 |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile | 4-point scale | Posted | Count of Participants | Participants | Week 4 |
|
|
12 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 | QM1114-DP in the LCL and the GL Areas | The investigational product (QM1114-DP) is a BoNT Type A. At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines. botulinum toxin neuromodulator: A dose of QM1114-DP will be injected in the GL area and in the LCL area. | 1 | 902 | 23 | 902 | 243 | 902 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Cholecystitis infective | Infections and infestations | Systematic Assessment |
| ||
| Post procedural infection | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Urosepsis | Infections and infestations | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal perforation | Gastrointestinal disorders | Systematic Assessment |
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| Adnocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
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| Cubital tunnel syndrome | Nervous system disorders | Systematic Assessment |
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| Presyncope | Nervous system disorders | Systematic Assessment |
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| Post procedural hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Goitre | Endocrine disorders | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | Systematic Assessment |
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| Trigger finger | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Suicide | Psychiatric disorders | Systematic Assessment |
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| Pelvic Pain | Reproductive system and breast disorders | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertensive urgency | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site Pain | General disorders | Systematic Assessment |
| ||
| Injection site bruising | General disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galderma Research & Development | Galderma Research & Development | 817-961-5000 | clinical.studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2021 | May 23, 2023 | SAP_001.pdf |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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