Nasolabial Folds
Conditions
Brief summary
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.
Interventions
DEVICESculptra Aesthetic, Lidocaine HCL
No intervention was administered during this extension study.
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705
Exclusion criteria
* Medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion * Other condition preventing the subject from entering the study in the Investigator's opinion * Participation in any interventional clinical study throughout the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96 | Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | At Weeks 72 and 96 (assessed in the current extension study) | FACE-Q™ appraisal of lines NLF scores were used to assess participant's treatment satisfaction. The sum of the participants FACE-Q™ appraisal of lines NLF scores was converted to a Rasch-transformed total score (ranged from 0 to 100) according to the FACE-Q™ 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). |
| Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Would You do the Treatment Again? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
| Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From Baseline of study 43USSA1705 (NCT03780244) up to Week 96 (assessed in the current extension study) | 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). |
| Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Weeks 72 and 96 (assessed in the current extension study) | 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Sculptra Aesthetic |
|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 7.61 |
| Baseline WAS (Right) | 2.8 units on a scale STANDARD_DEVIATION 0.79 |
| Baseline Wrinkle Assessment Scale (WAS) (Left) | 3.0 units on a scale STANDARD_DEVIATION 0.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type (FST) FST I | 2 Participants |
| Fitzpatrick Skin Type (FST) FST II | 7 Participants |
| Fitzpatrick Skin Type (FST) FST III | 16 Participants |
| Fitzpatrick Skin Type (FST) FST IV | 6 Participants |
| Fitzpatrick Skin Type (FST) FST V | 5 Participants |
| Fitzpatrick Skin Type (FST) FST VI | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 38 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 17 / 38 |
| serious Total, serious adverse events | 1 / 38 |
Outcome results
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).
Time frame: Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sculptra Aesthetic | Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96 | Left NLF: Change at Week 72 | -1.3 units on a scale | Standard Deviation 1.06 |
| Sculptra Aesthetic | Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96 | Right NLF: Change at Week 72 | -1.2 units on a scale | Standard Deviation 0.88 |
| Sculptra Aesthetic | Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96 | Left NLF: Change at Week 96 | -1.2 units on a scale | Standard Deviation 1.13 |
| Sculptra Aesthetic | Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96 | Right NLF: Change at Week 96 | -1.1 units on a scale | Standard Deviation 1.08 |
Secondary
FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
FACE-Q™ appraisal of lines NLF scores were used to assess participant's treatment satisfaction. The sum of the participants FACE-Q™ appraisal of lines NLF scores was converted to a Rasch-transformed total score (ranged from 0 to 100) according to the FACE-Q™ 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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sculptra Aesthetic | FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Week 72 | 69.8 score on a scale | Standard Deviation 25.05 |
| Sculptra Aesthetic | FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Week 96 | 70.2 score on a scale | Standard Deviation 25.46 |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sculptra Aesthetic | Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment | Week 72 | 35 Participants |
| Sculptra Aesthetic | Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment | Week 96 | 35 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sculptra Aesthetic | Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | Week 72 | 30 Participants |
| Sculptra Aesthetic | Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | Week 96 | 30 Participants |
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).
Time frame: From Baseline of study 43USSA1705 (NCT03780244) up to Week 96 (assessed in the current extension study)
Population: Extension population included all participants who entered the extension study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sculptra Aesthetic | Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Number of participants with Serious TEAEs | 1 Participants |
| Sculptra Aesthetic | Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Number of Participants with TEAEs | 24 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 96 | Dissatisfied | 2 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 96 | Very Dissatisfied | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 72 | Very Satisfied | 12 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 72 | Satisfied | 17 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 72 | Neutral (neither satisfied or dissatisfied) | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 72 | Dissatisfied | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 72 | Very Dissatisfied | 0 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 96 | Very Satisfied | 12 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 96 | Satisfied | 15 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 96 | Neutral (neither satisfied or dissatisfied) | 5 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 72 | Very Satisfied | 11 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 72 | Satisfied | 18 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 72 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 96 | Very Satisfied | 12 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 96 | Satisfied | 14 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 96 | Neutral (not satisfied or dissatisfied) | 6 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 96 | Dissatisfied | 2 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 96 | Very Dissatisfied | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 72 | Dissatisfied | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 72 | Very Dissatisfied | 0 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 72 | Very Satisfied | 14 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 72 | Satisfied | 14 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 72 | Neutral (neither satisfied or dissatisfied) | 4 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 72 | Dissatisfied | 2 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 72 | Very Dissatisfied | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 96 | Very Satisfied | 13 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 96 | Satisfied | 13 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 96 | Neutral (neither satisfied or dissatisfied) | 6 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 96 | Dissatisfied | 2 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 96 | Very Dissatisfied | 1 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 96 | Very Dissatisfied | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 72 | Very Satisfied | 14 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 72 | Satisfied | 13 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 72 | Neutral (neither satisfied or dissatisfied) | 5 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 72 | Dissatisfied | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 72 | Very Dissatisfied | 0 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 96 | Very Satisfied | 12 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 96 | Satisfied | 13 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 96 | Neutral (neither satisfied or dissatisfied) | 7 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 96 | Dissatisfied | 2 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | Week 72 | Very Satisfied | 17 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | Week 72 | Satisfied | 13 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | Week 96 | Very Dissatisfied | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | Week 72 | Neutral (neither satisfied or dissatisfied) | 2 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | Week 72 | Dissatisfied | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | Week 72 | Very Dissatisfied | 0 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | Week 96 | Very Satisfied | 13 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | Week 96 | Satisfied | 15 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | Week 96 | Neutral (neither satisfied or dissatisfied) | 4 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | Week 96 | Dissatisfied | 2 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 72 | Neutral (neither satisfied or dissatisfied) | 4 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 72 | Dissatisfied | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 72 | Very Satisfied | 12 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 72 | Satisfied | 16 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 72 | Very Dissatisfied | 0 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 96 | Very Satisfied | 11 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 96 | Satisfied | 14 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 96 | Neutral (neither satisfied or dissatisfied) | 7 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 96 | Dissatisfied | 2 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 96 | Very Dissatisfied | 1 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 72 | Very Satisfied | 11 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 72 | Satisfied | 16 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 72 | Neutral (neither satisfied or dissatisfied) | 5 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 72 | Dissatisfied | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 72 | Very Dissatisfied | 0 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 96 | Very Satisfied | 10 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 96 | Satisfied | 15 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 96 | Neutral (neither satisfied or dissatisfied) | 5 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 96 | Dissatisfied | 4 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 96 | Very Dissatisfied | 1 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 72 | Very Satisfied | 13 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 72 | Satisfied | 18 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 72 | Neutral (not satisfied or dissatisfied) | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 72 | Dissatisfied | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 72 | Very Dissatisfied | 0 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 96 | Very Satisfied | 13 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 96 | Satisfied | 14 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 96 | Neutral (not satisfied or dissatisfied) | 4 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 96 | Dissatisfied | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 96 | Very Dissatisfied | 1 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 72 | Yes | 32 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 72 | No | 3 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 96 | Yes | 32 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 96 | No | 3 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 72 | Yes | 33 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 72 | No | 2 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 96 | Yes | 31 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 96 | No | 4 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 72 | Agree | 14 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 72 | Neither agree or disagree | 2 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 72 | Disagree | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 72 | Strong Disagree | 0 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 96 | Strongly Agree | 20 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 96 | Disagree | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 72 | Strongly Agree | 18 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 96 | Agree | 11 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 96 | Neither agree or disagree | 2 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 96 | Strong Disagree | 1 Participants |
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).
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 72 | Strongly Agree | 26 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 96 | Neither Agree or Disagree | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 72 | Agree | 7 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 72 | Neither Agree or Disagree | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 72 | Disagree | 0 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 72 | Strongly Disagree | 1 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 96 | Strongly Agree | 20 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 96 | Agree | 13 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 96 | Disagree | 0 Participants |
| Sculptra Aesthetic | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 96 | Strongly Disagree | 1 Participants |