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The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active arm - QM1114-DP | Active Comparator | a Botulinum Toxin Type A (BoNT-A) |
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| Inactive arm - Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QM1114-DP | Biological | QM1114-DP |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1 | Participant assessment at Month 1 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a participant who responded "improved," "much improved," or "very much improved" on the participant GAIS at maximum frown. Missing data is imputed as no change (non-responder). | At Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card | Following treatment at baseline, participants were asked to record their assessment of study treatment response in a diary card on Days 0 through 7. They were asked to respond "yes" or "no" to the following question: "Since being injected, have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows) when you frown?" Response to treatment effect given by a Participant on first day as "yes" to the diary question. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Homewood | Alabama | 35209 | United States | ||
| Galderma Research Site |
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A total of 132 participants were enrolled and treated in this study.
This study was conducted at 9 investigational centers in the United States (US) from 09 May 2022 to 01 September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: QM1114-DP | Participants received a single dose of 50 U (0.5 mL) (Milliliter) QM1114-DP intramuscularly (IM), divided into 5 equal aliquots injected into the glabellar area (10 U [0.1 mL] per injection point). |
| FG001 | Placebo Comparator: Placebo |
| 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 | Mar 21, 2022 | Aug 27, 2024 |
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Parallel assignment
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| Biological |
Placebo |
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| At Days 0 through 7 post-treatment |
| Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Participant assessment From Day 1 through Month 12 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a Participant who responded "improved," "much improved," or "very much improved" on the GAIS at maximum frown. This analysis is based on observed cases. | From Day 1 through Month 12 |
| Manhattan Beach |
| California |
| 90266 |
| United States |
| Galderma Research Site | Vista | California | 92083 | United States |
| Galderma Research Site | Coral Gables | Florida | 33146 | United States |
| Galderma Research Site | Hunt Valley | Maryland | 21030 | United States |
| Galderma Research Site | Omaha | Nebraska | 68144 | United States |
| Galderma Research Site | Chapel Hill | North Carolina | 27517 | United States |
| Galderma Research Site | Pflugerville | Texas | 78660 | United States |
| Galderma Research Site | Spring | Texas | 77388 | United States |
Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point). |
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| NOT COMPLETED |
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Intent to treat (ITT) population included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: QM1114-DP | Participants received a single dose of 50 U (0.5 mL) QM1114-DP IM, divided into 5 equal aliquots injected into the glabellar area (10 U [0.1 mL] per injection point). |
| BG001 | Placebo Comparator: Placebo | Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point). |
| BG002 | 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 | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1 | Participant assessment at Month 1 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a participant who responded "improved," "much improved," or "very much improved" on the participant GAIS at maximum frown. Missing data is imputed as no change (non-responder). | Intent to treat (ITT) population included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. | Posted | Count of Participants | Participants | At Month 1 |
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| Secondary | Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card | Following treatment at baseline, participants were asked to record their assessment of study treatment response in a diary card on Days 0 through 7. They were asked to respond "yes" or "no" to the following question: "Since being injected, have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows) when you frown?" Response to treatment effect given by a Participant on first day as "yes" to the diary question. | ITT population included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. | Posted | Count of Participants | Participants | At Days 0 through 7 post-treatment |
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| Secondary | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Participant assessment From Day 1 through Month 12 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a Participant who responded "improved," "much improved," or "very much improved" on the GAIS at maximum frown. This analysis is based on observed cases. | ITT population included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. Here, "number analyzed" signifies participants in total observed cases at given time points. | Posted | Number | 95% Confidence Interval | participants | From Day 1 through Month 12 |
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From Day 1 up to end of study (Up to 12 Months)
Safety population included all participants who were treated with QM1114-DP and Placebo.
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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 | Experimental: QM1114-DP | Participants received a single dose of 50 U (0.5 mL) QM1114-DP IM, divided into 5 equal aliquots injected into the glabellar area (10 U [0.1 mL] per injection point). | 0 | 99 | 0 | 99 | 39 | 99 |
| EG001 | Placebo Comparator: Placebo | Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point). | 0 | 33 | 0 | 33 | 7 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Conjunctivitis bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Ureterolithiasis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Felipe Weinberg, MD, MPH | Galderma Research & Development, LLC | 817-961-5000 | aestheticclinicaltrials@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 8, 2022 | Aug 27, 2024 | SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| 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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| Participants |
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| Units | Counts |
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| Participants |
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