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To evaluate the long-term safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sculptra Aesthetic | Experimental | Participants who completed 48 weeks of Sculptra Aesthetic reconstituted with 8 milliliters (mL) of sterile water for injection (SWFI) in study 43USSA1705 (NCT03780244) were followed into this long-term extension study at Week 72 and Week 96 after baseline (i.e., Day 1/first treatment session with Sculptra Aesthetic in Study 43USSA1705 [NCT03780244]). No investigational product was provided during this extension study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sculptra Aesthetic, Lidocaine HCL | Device | No intervention was administered during this extension study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96 | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints. Lower scores indicate better outcome. Effectiveness is defined as change from baseline on both sides of the face using WAS at 72 and 96 weeks after the first treatment session. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | A responder was defined as a participant assessed as at least "Improved" (very much improved, much improved, and improved) on both sides of the face concurrently assessed using GAIS by participant. The 7-graded GAIS used by the participant to live assess the aesthetic improvement had responses as follows: (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3). Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Study Site | Scottsdale | Arizona | 85255 | United States | ||
| Galderma Study Site |
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A total of 38 participants entered this long-term extension study upon completion of Study 43USSA1705 (NCT03780244) (Week 48) and performed follow-up visits in this extension study at Week 72 and Week 96 after baseline (that is [i.e.], Day1/first treatment session in Study 43USSA1705 [NCT03780244]). No treatment was given during this extension study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sculptra Aesthetic | Participants who completed 48 weeks of Sculptra Aesthetic reconstituted with 8 milliliters (mL) of sterile water for injection (SWFI) in study 43USSA1705 (NCT03780244) were followed into this long-term extension study at Week 72 and Week 96 after baseline (i.e., Day 1/first treatment session with Sculptra Aesthetic in Study 43USSA1705 [NCT03780244]). No investigational product was provided during this extension study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The extension population included all participants who entered the extension study. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244).
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| ID | Title | Description |
|---|---|---|
| BG000 | Sculptra Aesthetic | Participants who completed 48 weeks of Sculptra Aesthetic reconstituted with 8 mL of SWFI in study 43USSA1705 (NCT03780244) were followed into this long-term extension study at Week 72 and Week 96 after baseline (i.e., Day 1/first treatment session with Sculptra Aesthetic in Study 43USSA1705 [NCT03780244]). No investigational product was provided during this extension study. |
| 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 | Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96 | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints. Lower scores indicate better outcome. Effectiveness is defined as change from baseline on both sides of the face using WAS at 72 and 96 weeks after the first treatment session. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome measure at given timepoints. | Posted | Mean | Standard Deviation | units on a scale | Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study) |
From Baseline of study 43USSA1705 (NCT03780244) up to Week 96 (assessed in the current extension study)
The data of this section was collected from baseline of study 43USSA1705 (NCT03780244) up to Week 96 of extension current study. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705. (NCT03780244).
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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 | Sculptra Aesthetic | Participants who completed 48 weeks of Sculptra Aesthetic reconstituted with 8 mL of SWFI in study 43USSA1705 (NCT03780244) were followed into this long-term extension study at Week 72 and Week 96 after baseline (i.e., Day 1/first treatment session with Sculptra Aesthetic in Study 43USSA1705 [NCT03780244]). No investigational product was provided during this extension study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corona virus infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | QMedAB | 18179615000 | 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 | Mar 2, 2020 | Feb 19, 2025 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 10, 2020 | Feb 20, 2024 | SAP_002.pdf |
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| At Weeks 72 and 96 (assessed in the current extension study) |
| Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment | A responder was defined as a participant assessed as at least "Improved" (very much improved, much improved, and improved) on both sides of the face concurrently assessed using GAIS by investigator. The 7-graded GAIS used by the participant to live assess the aesthetic improvement had responses as follows: (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3). Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705. (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| FACE-Qâ„¢ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | FACE-Qâ„¢ appraisal of lines NLF scores were used to assess participant's treatment satisfaction. The sum of the participants FACE-Qâ„¢ appraisal of lines NLF scores was converted to a Rasch-transformed total score (ranged from 0 to 100) according to the FACE-Qâ„¢ manual; a higher total score indicated greater participant satisfaction. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705. (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | A subject satisfaction question with responses Yes or No. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Would You do the Treatment Again? | A subject satisfaction question with responses Yes or No. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705. (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | A 5-point participant satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject 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: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | At Weeks 72 and 96 (assessed in the current extension study) |
| Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs of a clinical investigation in participants, whether or not related to the investigational device which included events related to the investigational product (IP) or the reference product, events related to the procedures involved and events that were anticipated as well as unanticipated. SAE: an AE resulting in death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. TEAE: any AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). | From Baseline of study 43USSA1705 (NCT03780244) up to Week 96 (assessed in the current extension study) |
| Bradenton |
| Florida |
| 34209 |
| United States |
| Galderma Study Site | Austin | Texas | 78746 | United States |
| Galderma Study Site | Spring | Texas | 77388 | United States |
| years |
|
| 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 |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fitzpatrick Skin Type (FST) | FST is a numerical classification scale for the color of skin from Type I to Type VI. Type I= always burns, never tans; Type II= usually burns, tans minimally (light colored but darker than fair); Type III= sometimes mild burn, tans uniformly (golden honey or olive); Type IV= burns minimally, always tan well (moderate brown); Type V= very rarely burns, tans very easily (dark brown); Type VI= never burns (deeply pigmented dark brown to darkest brown). A higher type was considered better. | Count of Participants | Participants |
|
| Baseline Wrinkle Assessment Scale (WAS) (Left) | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of nasolabial fold (NLF) wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator. Lower scores indicate better outcome. | Mean | Standard Deviation | units on a scale |
|
| Baseline WAS (Right) | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator. Lower scores indicate better outcome. | Mean | Standard Deviation | units on a scale |
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| Secondary | Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | A responder was defined as a participant assessed as at least "Improved" (very much improved, much improved, and improved) on both sides of the face concurrently assessed using GAIS by participant. The 7-graded GAIS used by the participant to live assess the aesthetic improvement had responses as follows: (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3). Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment | A responder was defined as a participant assessed as at least "Improved" (very much improved, much improved, and improved) on both sides of the face concurrently assessed using GAIS by investigator. The 7-graded GAIS used by the participant to live assess the aesthetic improvement had responses as follows: (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3). Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705. (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | FACE-Qâ„¢ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | FACE-Qâ„¢ appraisal of lines NLF scores were used to assess participant's treatment satisfaction. The sum of the participants FACE-Qâ„¢ appraisal of lines NLF scores was converted to a Rasch-transformed total score (ranged from 0 to 100) according to the FACE-Qâ„¢ manual; a higher total score indicated greater participant satisfaction. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705. (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | A subject satisfaction question with responses Yes or No. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject Satisfaction With Treatment: Would You do the Treatment Again? | A subject satisfaction question with responses Yes or No. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705. (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | A 5-point participant satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject 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: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
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| Secondary | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244). | The extension population included all participants who entered the extension study. Here, "overall number of participants analyzed" refers to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Weeks 72 and 96 (assessed in the current extension study) |
|
|
|
| Secondary | Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs of a clinical investigation in participants, whether or not related to the investigational device which included events related to the investigational product (IP) or the reference product, events related to the procedures involved and events that were anticipated as well as unanticipated. SAE: an AE resulting in death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. TEAE: any AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). | Extension population included all participants who entered the extension study. | Posted | Count of Participants | Participants | From Baseline of study 43USSA1705 (NCT03780244) up to Week 96 (assessed in the current extension study) |
|
|
|
| 0 |
| 38 |
| 1 |
| 38 |
| 17 |
| 38 |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
per site CTA
| No |
|
| No |
|
| Disagree |
|
| Strong Disagree |
|
| Week 96 |
|
| Disagree |
|
| Strongly Disagree |
|
| Week 96 |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 96 |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 96 |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 96 |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 96 |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 96 |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 96 |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 96 |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 96 |
|