Trial Outcomes & Findings for Extension Study for 43USSA1705 (NCT NCT04225273)
NCT ID: NCT04225273
Last Updated: 2025-03-12
Results Overview
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).
COMPLETED
NA
38 participants
Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study)
2025-03-12
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Extension Study for 43USSA1705
Baseline characteristics by cohort
| Measure |
Sculptra Aesthetic
n=38 Participants
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.
|
|---|---|
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Age, Continuous
|
54.2 years
STANDARD_DEVIATION 7.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST I
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST II
|
7 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST III
|
16 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST IV
|
6 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST V
|
5 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST VI
|
2 Participants
n=5 Participants
|
|
Baseline Wrinkle Assessment Scale (WAS) (Left)
|
3.0 units on a scale
STANDARD_DEVIATION 0.70 • n=5 Participants
|
|
Baseline WAS (Right)
|
2.8 units on a scale
STANDARD_DEVIATION 0.79 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
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|---|---|
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Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
Week 72
|
30 Participants
|
|
Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
Week 96
|
30 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
|
Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment
Week 72
|
35 Participants
|
|
Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment
Week 96
|
35 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
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FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Week 72
|
69.8 score on a scale
Standard Deviation 25.05
|
|
FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Week 96
|
70.2 score on a scale
Standard Deviation 25.46
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
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Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 72 · Yes
|
33 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 72 · No
|
2 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 96 · Yes
|
31 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 96 · No
|
4 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
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Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 96 · Yes
|
32 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 72 · Yes
|
32 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 72 · No
|
3 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 96 · No
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
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|---|---|
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Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 72 · Agree
|
14 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 72 · Neither agree or disagree
|
2 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 72 · Disagree
|
1 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 72 · Strong Disagree
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 96 · Neither agree or disagree
|
2 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 96 · Disagree
|
1 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 72 · Strongly Agree
|
18 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 96 · Strongly Agree
|
20 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 96 · Agree
|
11 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 96 · Strong Disagree
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
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|---|---|
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Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 96 · Agree
|
13 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 96 · Neither Agree or Disagree
|
1 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 96 · Disagree
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 72 · Strongly Agree
|
26 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 72 · Agree
|
7 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 72 · Neither Agree or Disagree
|
1 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 72 · Disagree
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 72 · Strongly Disagree
|
1 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 96 · Strongly Agree
|
20 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 96 · Strongly Disagree
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 72 · Very Satisfied
|
14 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 72 · Satisfied
|
14 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 72 · Neutral (neither satisfied or dissatisfied)
|
4 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 72 · Dissatisfied
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 72 · Very Dissatisfied
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 96 · Very Satisfied
|
13 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 96 · Satisfied
|
13 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 96 · Neutral (neither satisfied or dissatisfied)
|
6 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 96 · Dissatisfied
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 96 · Very Dissatisfied
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 96 · Very Dissatisfied
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 72 · Dissatisfied
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 72 · Very Dissatisfied
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 96 · Very Satisfied
|
10 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 72 · Very Satisfied
|
11 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 72 · Satisfied
|
16 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 72 · Neutral (neither satisfied or dissatisfied)
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 96 · Satisfied
|
15 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 96 · Neutral (neither satisfied or dissatisfied)
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 96 · Dissatisfied
|
4 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 72 · Very Dissatisfied
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 72 · Very Satisfied
|
12 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 72 · Satisfied
|
16 Participants
|
|
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
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 72 · Dissatisfied
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 96 · Very Satisfied
|
11 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 96 · Satisfied
|
14 Participants
|
|
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
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 96 · Dissatisfied
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 96 · Very Dissatisfied
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 96 · Dissatisfied
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 96 · Very Dissatisfied
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 72 · Very Satisfied
|
14 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 72 · Satisfied
|
13 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 72 · Neutral (neither satisfied or dissatisfied)
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 72 · Dissatisfied
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 72 · Very Dissatisfied
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 96 · Very Satisfied
|
12 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 96 · Satisfied
|
13 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 96 · Neutral (neither satisfied or dissatisfied)
|
7 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 72 · Very Satisfied
|
12 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 72 · Satisfied
|
17 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 72 · Neutral (neither satisfied or dissatisfied)
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 72 · Very Dissatisfied
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 96 · Very Satisfied
|
12 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 96 · Satisfied
|
15 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 96 · Neutral (neither satisfied or dissatisfied)
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 96 · Dissatisfied
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 96 · Very Dissatisfied
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 72 · Dissatisfied
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Week 72 · Very Satisfied
|
17 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Week 72 · Satisfied
|
13 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Week 72 · Neutral (neither satisfied or dissatisfied)
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Week 72 · Dissatisfied
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Week 72 · Very Dissatisfied
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Week 96 · Satisfied
|
15 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Week 96 · Neutral (neither satisfied or dissatisfied)
|
4 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Week 96 · Dissatisfied
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Week 96 · Very Dissatisfied
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Week 96 · Very Satisfied
|
13 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 72 · Very Satisfied
|
11 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 72 · Satisfied
|
18 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 96 · Dissatisfied
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 96 · Very Dissatisfied
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 96 · Neutral (not satisfied or dissatisfied)
|
6 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 72 · Neutral (not satisfied or dissatisfied)
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 72 · Dissatisfied
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 72 · Very Dissatisfied
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 96 · Very Satisfied
|
12 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 96 · Satisfied
|
14 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=35 Participants
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.
|
|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 72 · Neutral (not satisfied or dissatisfied)
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 72 · Dissatisfied
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 72 · Very Dissatisfied
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 96 · Very Satisfied
|
13 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 96 · Satisfied
|
14 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 96 · Neutral (not satisfied or dissatisfied)
|
4 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 96 · Very Dissatisfied
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 72 · Very Satisfied
|
13 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 72 · Satisfied
|
18 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 96 · Dissatisfied
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sculptra Aesthetic
n=38 Participants
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.
|
|---|---|
|
Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Number of Participants with TEAEs
|
24 Participants
|
|
Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Number of participants with Serious TEAEs
|
1 Participants
|
Adverse Events
Sculptra Aesthetic
Serious adverse events
| Measure |
Sculptra Aesthetic
n=38 participants at risk
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.
|
|---|---|
|
Psychiatric disorders
Anxiety
|
2.6%
1/38 • Number of events 2 • 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).
|
Other adverse events
| Measure |
Sculptra Aesthetic
n=38 participants at risk
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.
|
|---|---|
|
Infections and infestations
Corona virus infection
|
10.5%
4/38 • Number of events 4 • 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).
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
3/38 • Number of events 3 • 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).
|
|
Infections and infestations
Urinary tract infection
|
5.3%
2/38 • Number of events 2 • 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).
|
|
Nervous system disorders
Headache
|
10.5%
4/38 • Number of events 5 • 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).
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.3%
2/38 • Number of events 3 • 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).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.3%
2/38 • Number of events 2 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee per site CTA
- Publication restrictions are in place
Restriction type: OTHER