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This study to assess aesthetic improvement following treatment with QM1114-DP.
This was an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QM1114-DP | Experimental | QM1114-DP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QM1114-DP | Biological | QM1114-DP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responders Rate Using the Global Aesthetic Improvement Scale (GAIS) at Maximum Frown (Glabellar Lines) | The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your glabellar lines (lines between your eyebrows) at maximum frown compared with immediately before the injection?". Participants were then instructed to select on rating that best describes the degree to which the appearance of their glabellar lines at maximum frown has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum frown. | Month 1 |
| Responders Rate Using the GAIS at Maximum Smile (Lateral Canthal Lines) | The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your lateral canthal lines (crow's feet) at maximum smile compared with immediately before the injection". Participants were then instructed to select on rating that best describes the degree to which the appearance of their lateral canthal lines at maximum smile has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum smile. | Month 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | New York | New York | 10021 | United States |
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A total of 26 participants were screened. Out of which 25 participants were enrolled and received study product.
This study was conducted at a single site in the United States of America from 23 January 2023 to 23 June 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | QM1114-DP | Participants received intramuscular injections of QM1114-DP 50 units in the glabellar region and QM1114-DP 60 units in the lateral canthus lines areas on Day 0. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis was performed on the safety set which included all participants who were injected in at least one of the glabellar lines or lateral canthal lines.
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| ID | Title | Description |
|---|---|---|
| BG000 | QM1114-DP | Participants received intramuscular injections of QM1114-DP 50 units in the glabellar region and QM1114-DP 60 units in the lateral canthus lines areas on Day 0. |
| 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 |
| 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 | Responders Rate Using the Global Aesthetic Improvement Scale (GAIS) at Maximum Frown (Glabellar Lines) | The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your glabellar lines (lines between your eyebrows) at maximum frown compared with immediately before the injection?". Participants were then instructed to select on rating that best describes the degree to which the appearance of their glabellar lines at maximum frown has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum frown. | Analysis was performed on the full analysis set which included all participants who were injected in both glabellar lines and lateral canthal lines. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 1 |
|
From Day 0 up to Month 4
Analysis was performed on the safety set which included all participants who were injected in at least one of the glabellar lines and lateral canthal lines.
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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 | Participants received intramuscular injections of QM1114-DP 50 units in the glabellar region and QM1114-DP 60 units in the lateral canthus lines areas on Day 0. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA Version 25.1 | Non-systematic Assessment | The event was considered related to the injection procedure and not the study product. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galderma Clinical Project Manager | Galderma | +1 817-961-5000 | aestheticclinicaltrials@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 | Dec 5, 2022 | Mar 25, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2022 | May 4, 2026 | SAP_002.pdf |
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Open Label single site study for treatment of GL and LCL with single treatment of QM1114-DP
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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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| Title |
|---|
| Description |
|---|
| OG000 | QM1114-DP | Participants received intramuscular injections of QM1114-DP 50 units in the glabellar region and QM1114-DP 60 units in the lateral canthus lines areas on Day 0. |
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| Primary | Responders Rate Using the GAIS at Maximum Smile (Lateral Canthal Lines) | The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your lateral canthal lines (crow's feet) at maximum smile compared with immediately before the injection". Participants were then instructed to select on rating that best describes the degree to which the appearance of their lateral canthal lines at maximum smile has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum smile. | Analysis was performed on the full analysis set which included all participants who were injected in both glabellar lines and lateral canthal lines. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 1 |
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| 0 |
| 25 |
| 0 |
| 25 |
| 2 |
| 25 |
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