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To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Sculptra Aesthetic | Experimental | Subjects in this group will be treated with Sculptra aesthetic. Subjects will be followed for up to 12 months for safety and effectiveness data collection |
|
| Group B: No Treatment | Experimental | Subjects in this group will be followed for up to 12 months with no additional treatment for long-term safety and effectiveness data collection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection | Device | Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on as scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment. | At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on a scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment. |
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Inclusion Criteria:
Exclusion Criteria:
1. For subjects eligible for treatment in the extension study, the exclusion criteria for study 43USSA1812 applies.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Scottsdale | Arizona | 85255 | United States | ||
| Galderma Research Site |
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A total of 111 participants were enrolled in this extension study upon completion of 43USSA1812 (NCT04124692) study.
The study was conducted at 13 sites at the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Sculptra Aesthetic | Participants in this group were treated with Sculptra aesthetic. Participants were followed for up to 12 months for safety and effectiveness data collection in this study. |
| FG001 | Group B: No Treatment | Participants in this group followed for long-term safety and effectiveness with no additional treatment. Participants were followed for up to 12 months for safety and effectiveness data collection in this study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Sculptra Aesthetic | Participants in this group were treated with Sculptra aesthetic. Participants were followed for up to 12 months for safety and effectiveness data collection in this study. |
| BG001 | Group B: No Treatment |
| 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 | Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on as scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Number | Percentage of participants | At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
|
From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
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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 | Group A: Sculptra Aesthetic | Participants in this group were treated with Sculptra aesthetic. Participants were followed for up to 12 months for safety and effectiveness data collection in this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Development | Q-Med AB | +46184749000 | reception.seupp@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 | Jul 29, 2020 | Jul 30, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2022 | Jul 30, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Subjects originally randomized to Control Group at baseline in the pivotal 43USSA1812 study will be offered treatment with Sculptra Aesthetic in the extension study. Subjects originally randomized to Treatment Group at baseline in the pivotal 43USSA1812 study will be continued to be followed up during the extension study without further treatment.
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| At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to rate their aesthetic improvement of the cheek wrinkles on a scale from "Very Much Improved" to "Very Much Worse" in a live assessment. | At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment | GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to rate aesthetic improvement of the cheek wrinkles on a scale from "Very Much Improved" to "Very Much Worse" in a live assessment. | At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Satisfaction With Treatment: Does the Treatment Make You Look Younger? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither Agree or Disagree, Disagree, Strongly Disagree. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Subject Satisfaction: Would You Recommend the Treatment to a Friend? | A subject satisfaction question with responses Yes or No. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Subject Satisfaction: Would You do the Treatment Again? | A subject satisfaction question with responses Yes or No. | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement. | Baseline, Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important. medical event. TEAEs included both serious and non-serious TEAEs. | From start of study drug administration up to end of the study (up to Month 24) (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
| Encino |
| California |
| 91436 |
| United States |
| Galderma Research Site | Redondo Beach | California | 90277 | United States |
| Galderma Research site | San Diego | California | 92121 | United States |
| Galderma Research Site | Washington D.C. | District of Columbia | 20037 | United States |
| Galderma Research Site | Coral Gables | Florida | 33143 | United States |
| Galderma Research Site | Alpharetta | Georgia | 30022 | United States |
| Galderma Research Site | New Orleans | Louisiana | 70115 | United States |
| Galderma Research Site | Rockville | Maryland | 20852 | United States |
| Galderma Research Site | New York | New York | 10021 | United States |
| Galderma Research Site | New York | New York | 10028 | United States |
| Galderma Research Site | Dallas | Texas | 75254 | United States |
| Galderma Research Site | Spring | Texas | 77388 | United States |
| Medical reason |
|
Participants in this group followed for long-term safety and effectiveness with no additional treatment. Participants were followed for up to 12 months for safety and effectiveness data collection in this study.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fitzpatrick skin type (FST) | FST I: white; very fair; red or blond hair; blue eyes; freckles. always burns, never tans. FST II: white; fair; red or blond hair; blue, hazel or green eyes. usually burns, tans with difficulty. FST III: cream white; fair with any eye or hair color; very common. sometimes mild burn, gradually tans. FST IV: brown; typical Mediterranean Caucasian skin. rarely burns, tans with ease. FST V: dark brown; Middle Eastern skin types. very rarely burns, tans very easily. FST VI: Skin color - black. Skin Characteristics - never burns, tans very easily. | Count of Participants | Participants |
|
| OG000 |
| Group A: Sculptra Aesthetic |
Participants in this group were treated with Sculptra aesthetic. Participants were followed for up to 12 months for safety and effectiveness data collection in this study. |
| OG001 | Group B: No Treatment | Participants in this group followed for long-term safety and effectiveness with no additional treatment. Participants were followed for up to 12 months for safety and effectiveness data collection in this study. |
|
|
| Secondary | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on a scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Number | Percentage of participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
|
|
|
| Secondary | Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to rate their aesthetic improvement of the cheek wrinkles on a scale from "Very Much Improved" to "Very Much Worse" in a live assessment. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Number | Percentage of participants | At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
|
|
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| Secondary | Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment | GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to rate aesthetic improvement of the cheek wrinkles on a scale from "Very Much Improved" to "Very Much Worse" in a live assessment. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Number | Percentage of participants | At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
|
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| Secondary | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither Agree or Disagree, Disagree, Strongly Disagree. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | A subject satisfaction question with responses Yes or No. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Subject Satisfaction: Would You do the Treatment Again? | A subject satisfaction question with responses Yes or No. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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| Secondary | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement. | The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Mean | Standard Deviation | score on a scale | Baseline, Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
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|
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important. medical event. TEAEs included both serious and non-serious TEAEs. | The extension population included all participants entering the extension study. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Posted | Count of Participants | Participants | From start of study drug administration up to end of the study (up to Month 24) (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 11 |
| 39 |
| EG001 | Group B: No Treatment | Participants in this group followed for long-term safety and effectiveness with no additional treatment. Participants were followed for up to 12 months for safety and effectiveness data collection in this study. | 0 | 72 | 1 | 72 | 4 | 72 |
| Injection site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Postmenopause | Social circumstances | MedDRA 23.1 | Systematic Assessment |
|
Not provided
| At Month 21 |
|
|
| At Month 24 |
|
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Very good |
|
| Good |
|
| Satisfactory |
|
| Not satisfied |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Very Good |
|
| Good |
|
| Satisfactory |
|
| Not Satisfied |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Very good |
|
| Good |
|
| Satisfactory |
|
| Not Satisfied |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Very Good |
|
| Good |
|
| Satisfactory |
|
| Not Satisfied |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Very good |
|
| Good |
|
| Satisfactory |
|
| Not Satisfied |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Very good |
|
| Good |
|
| Satisfactory |
|
| Not Satisfied |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Very good |
|
| Good |
|
| Satisfactory |
|
| Not Satisfied |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Very good |
|
| Good |
|
| Satisfactory |
|
| Not Satisfied |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Very good |
|
| Good |
|
| Satisfactory |
|
| Not Satisfied |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Very good |
|
| Good |
|
| Satisfactory |
|
| Not satisfied |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Agree |
|
| Neither Agree or Disagree |
|
| Disagree |
|
| Strongly Disagree |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| Agree |
|
| Neither agree or Disagree |
|
| Disagree |
|
| Strongly disagree |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| No |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| No |
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| At Month 21 |
|
|
| At Month 24 |
|
|