Trial Outcomes & Findings for Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency (NCT NCT04132518)
NCT ID: NCT04132518
Last Updated: 2025-01-07
Results Overview
MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
205 participants
Primary outcome timeframe
Baseline, Month 12
Results posted on
2025-01-07
Participant Flow
The study was conducted at 6 centers in China from 12 November 2019 to 18 July 2022.
A total of 16 participants were enrolled into Group A and 189 participants were enrolled into Group B. Out of 189 participants in Group B, 126 participants randomized in treatment group and 63 participants in control group or no treatment group.
Participant milestones
| Measure |
Group A: Sculptra
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Sculptra
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
126
|
63
|
|
Overall Study
Treated
|
16
|
124
|
0
|
|
Overall Study
COMPLETED
|
16
|
117
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
9
|
1
|
Reasons for withdrawal
| Measure |
Group A: Sculptra
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Sculptra
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Overall Study
Prematurely withdrawn from the study
|
0
|
9
|
1
|
Baseline Characteristics
Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Baseline characteristics by cohort
| Measure |
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
n=63 Participants
Participants in Group B did not receive any treatment and followed up for 12 months.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
183 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Chinese Han
|
16 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
16 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
n=63 Participants
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants With 1 Point Improvement From Baseline on the Medicis Midface Volume Scale (MMVS) as Measured by the Blinded Evaluator at Month 12
|
69.4 Percentage of participants
Interval 60.4 to 77.3
|
68.8 Percentage of participants
Interval 41.3 to 89.0
|
1.6 Percentage of participants
Interval 0.0 to 8.5
|
SECONDARY outcome
Timeframe: Treatment group: Baseline, Months 6, 9, 18 and 24; Control group: Baseline, Months 6 and 9Population: Full analysis set (FAS) included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints.
MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
n=62 Participants
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator
At Month 6
|
68.5 Percentage of participants
Interval 59.6 to 76.6
|
81.3 Percentage of participants
Interval 54.4 to 96.0
|
3.2 Percentage of participants
Interval 0.4 to 11.2
|
|
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator
At Month 9
|
68.0 Percentage of participants
Interval 59.0 to 76.2
|
62.5 Percentage of participants
Interval 35.4 to 84.8
|
3.2 Percentage of participants
Interval 0.4 to 11.2
|
|
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator
At Month 18
|
59.3 Percentage of participants
Interval 49.9 to 68.3
|
68.8 Percentage of participants
Interval 41.3 to 89.0
|
—
|
|
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator
At Month 24
|
59.0 Percentage of participants
Interval 49.5 to 68.0
|
56.3 Percentage of participants
Interval 29.9 to 80.2
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints.
MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
n=62 Participants
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator
At Month 9
|
80.3 Percentage of participants
Interval 72.2 to 87.0
|
93.8 Percentage of participants
Interval 69.8 to 99.8
|
4.8 Percentage of participants
Interval 1.0 to 13.5
|
|
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator
At Month 6
|
81.5 Percentage of participants
Interval 73.5 to 87.9
|
93.8 Percentage of participants
Interval 69.8 to 99.8
|
6.5 Percentage of participants
Interval 1.8 to 15.7
|
|
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator
At Month 12
|
82.8 Percentage of participants
Interval 74.9 to 89.0
|
87.5 Percentage of participants
Interval 61.7 to 98.4
|
6.5 Percentage of participants
Interval 1.8 to 15.7
|
|
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator
At Month 18
|
72.0 Percentage of participants
Interval 63.0 to 79.9
|
87.5 Percentage of participants
Interval 61.7 to 98.4
|
—
|
|
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator
At Month 24
|
73.5 Percentage of participants
Interval 64.5 to 81.2
|
62.5 Percentage of participants
Interval 35.4 to 84.8
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints.
Total volume change from baseline over time (both sides of the face combined) was calculated by a digital 3D image analysis.
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
n=62 Participants
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Total Volume Change From Baseline Over Time of the Right and Left Midface Areas
Month 6
|
1.96 milliliter (mL)
Standard Deviation 1.03
|
2.15 milliliter (mL)
Standard Deviation 1.19
|
0.15 milliliter (mL)
Standard Deviation 0.82
|
|
Total Volume Change From Baseline Over Time of the Right and Left Midface Areas
Month 9
|
2.46 milliliter (mL)
Standard Deviation 1.26
|
2.63 milliliter (mL)
Standard Deviation 1.59
|
0.13 milliliter (mL)
Standard Deviation 0.72
|
|
Total Volume Change From Baseline Over Time of the Right and Left Midface Areas
Month 12
|
2.81 milliliter (mL)
Standard Deviation 1.28
|
2.74 milliliter (mL)
Standard Deviation 1.72
|
0.20 milliliter (mL)
Standard Deviation 0.83
|
|
Total Volume Change From Baseline Over Time of the Right and Left Midface Areas
Month 18
|
2.94 milliliter (mL)
Standard Deviation 1.35
|
3.27 milliliter (mL)
Standard Deviation 1.71
|
—
|
|
Total Volume Change From Baseline Over Time of the Right and Left Midface Areas
Month 24
|
3.00 milliliter (mL)
Standard Deviation 1.48
|
3.10 milliliter (mL)
Standard Deviation 1.38
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints.
The 5-graded GAIS was used to live assess the aesthetic improvement of the midface fullness of both sides of the participant's face as compared to photographs taken before treatment. Each midface side was rated separately. Rating and its Description:1. Very much improved (Optimal cosmetic result for the implant in this participant), 2. Much improved (Marked improvement in appearance from the original condition),3. Improved (Obvious improvement in appearance from the original condition), 4. No change (The appearance is essentially the same as original condition), 5. Worse (The appearance is worse than the original condition). Responders are those with a rating of at least improved. Participants with a GAIS rating of 'Very much improved', 'Much improved', or 'Improved' are defined as responders. Percentage of responders," according to the GAIS on both sides of the face combined, as assessed by the Treating Investigator was reported.
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
n=62 Participants
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator
Months 12
|
96.7 Percentage of responders
Interval 91.8 to 99.1
|
100.0 Percentage of responders
Interval 79.4 to 100.0
|
1.6 Percentage of responders
Interval 0.0 to 8.7
|
|
Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator
Month 6
|
97.6 Percentage of responders
Interval 93.1 to 99.5
|
100.0 Percentage of responders
Interval 79.4 to 100.0
|
3.2 Percentage of responders
Interval 0.4 to 11.2
|
|
Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator
Month 9
|
98.4 Percentage of responders
Interval 94.2 to 99.8
|
93.8 Percentage of responders
Interval 69.8 to 99.8
|
1.6 Percentage of responders
Interval 0.0 to 8.7
|
|
Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator
Month 18
|
98.3 Percentage of responders
Interval 94.0 to 99.8
|
100.0 Percentage of responders
Interval 79.4 to 100.0
|
—
|
|
Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator
Month 24
|
95.7 Percentage of responders
Interval 90.3 to 98.6
|
93.8 Percentage of responders
Interval 69.8 to 99.8
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints.
The 5-graded GAIS was used to live assess the aesthetic improvement of the midface fullness of both sides of the participant's face as compared to photographs taken before treatment. Each midface side was rated separately. Rating and its Description: 1. Very much improved (Optimal cosmetic result for the implant in this participant), 2. Much improved (Marked improvement in appearance from the original condition),3. Improved (Obvious improvement in appearance from the original condition), 4. No change (The appearance is essentially the same as original condition), 5. Worse (The appearance is worse than the original condition). Responders are those with a rating of at least improved. Participants with a GAIS rating of 'Very much improved', 'Much improved', or 'Improved' are defined as responders. Percentage of responders," according to the GAIS on both sides of the face combined, as assessed by the Participant was reported.
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
n=62 Participants
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant
Month 6
|
96.0 Percentage of responders
Interval 90.8 to 98.7
|
100.0 Percentage of responders
Interval 79.4 to 100.0
|
1.6 Percentage of responders
Interval 0.0 to 8.7
|
|
Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant
Month 9
|
95.9 Percentage of responders
Interval 90.7 to 98.7
|
93.8 Percentage of responders
Interval 69.8 to 99.8
|
0.0 Percentage of responders
Interval 0.0 to 0.1
|
|
Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant
Month 12
|
95.1 Percentage of responders
Interval 89.6 to 98.2
|
100.0 Percentage of responders
Interval 79.4 to 100.0
|
0.0 Percentage of responders
Interval 0.0 to 0.1
|
|
Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant
Month 18
|
92.4 Percentage of responders
Interval 86.0 to 96.5
|
100.0 Percentage of responders
Interval 79.4 to 100.0
|
—
|
|
Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant
Month 24
|
89.7 Percentage of responders
Interval 82.8 to 94.6
|
100.0 Percentage of responders
Interval 79.4 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group.
The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 1 was a YES or NO question pertaining to satisfaction with study treatment: Do you think your Cheek Volume deficit and/or Contour Deficiency has been improved with the treatment?
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment
Month 6
|
93.5 percentage of participants
|
93.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment
Month 9
|
95.9 percentage of participants
|
93.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment
Month 12
|
94.3 percentage of participants
|
93.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment
Month 18
|
92.4 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment
Month 24
|
94.0 percentage of participants
|
100.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group.
The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 2 was a YES or NO question pertaining to naturalness of the study treatment: Do you think that the overall result of the treatment looks natural?
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural
Month 6
|
98.4 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural
Month 9
|
97.5 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural
Month 12
|
98.4 percentage of participants
|
93.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural
Month 18
|
97.5 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural
Month 24
|
97.4 percentage of participants
|
93.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group.
The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 3 was answered on a 4-grade scale: Would you say that the study treatment: Surpass your expectations/Meet your expectations/ Do Meet your expectations/You did not have any specific expectations before the injections?
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
Month 24: Surpass your expectations
|
20.5 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
Month 6: Meet your expectations
|
69.4 percentage of participants
|
62.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
Month 6: Surpass your expectations
|
12.9 percentage of participants
|
31.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
Month 9: Meet your expectations
|
75.4 percentage of participants
|
62.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
Month 9: Surpass your expectations
|
9.8 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
Month 12: Meet your expectations
|
73.8 percentage of participants
|
62.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
Month 12: Surpass your expectations
|
13.9 percentage of participants
|
31.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
Month 18: Meet your expectations
|
67.8 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
Month 18: Surpass your expectations
|
17.8 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
Month 24: Meet your expectations
|
67.5 percentage of participants
|
43.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group.
The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 4 was a yes or no question: Do you think that the treatment brings you more: Youth/Beauty/Harmony/Symmetrical appearance/Pep/Liveliness/Freshened look/Self-esteem/confidence.
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 12 : Harmony
|
47.5 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 18: Pep/Liveliness /Freshened look
|
39.8 percentage of participants
|
68.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 18: Selfesteem/ confidence
|
28.8 percentage of participants
|
31.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 24 : Pep/Liveliness /Freshened look
|
44.4 percentage of participants
|
37.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 6 : Youth
|
58.1 percentage of participants
|
87.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 6 : Beauty
|
29.8 percentage of participants
|
31.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 6 : Harmony
|
41.1 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 6 : Symmetrical appearance
|
24.2 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 6 : Pep/Liveliness /Freshened look
|
44.4 percentage of participants
|
12.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 6 : Selfesteem/ confidence
|
25.8 percentage of participants
|
31.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 9: Youth
|
55.7 percentage of participants
|
62.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 9 : Beauty
|
34.4 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 9 : Harmony
|
50.0 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 9: Symmetrical appearance
|
27.0 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 9: Pep/Liveliness /Freshened look
|
41.8 percentage of participants
|
56.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 9 : Selfesteem/ confidence
|
22.1 percentage of participants
|
18.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 12: Youth
|
60.7 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 12 : Beauty
|
28.7 percentage of participants
|
37.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 12: Symmetrical appearance
|
32.0 percentage of participants
|
31.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 12 : Pep/Liveliness /Freshened look
|
36.9 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 12: Selfesteem/ confidence
|
27.9 percentage of participants
|
37.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 18: Youth
|
61.9 percentage of participants
|
68.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 18 : Beauty
|
29.7 percentage of participants
|
37.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 18 : Harmony
|
48.3 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 18 : Symmetrical appearance
|
22.0 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 24 : Youth
|
59.0 percentage of participants
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 24 : Beauty
|
38.5 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 24 : Harmony
|
50.4 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 24 : Symmetrical appearance
|
31.6 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
Month 24 : Selfesteem/ confidence
|
26.5 percentage of participants
|
37.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group.
The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 5 was a yes or no question: Would you say that you feel more attractive?
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants Agreeing That They Feel More Attractive by the Treatment
Month 18: Yes
|
84.7 percentage of participants
|
93.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel More Attractive by the Treatment
Month 6: Yes
|
80.6 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel More Attractive by the Treatment
Month 9: Yes
|
85.2 percentage of participants
|
93.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel More Attractive by the Treatment
Month 12 : Yes
|
86.9 percentage of participants
|
93.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel More Attractive by the Treatment
Month 24 : Yes
|
88.9 percentage of participants
|
87.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group.
The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 6 was answered on a 5-grade scale: How do you feel about yourself since the treatment was performed? Very much better / Much better / Somewhat better / The same / Worse. Percentage of participants who responded Very much better / Much better / Somewhat better were reported in this outcome measure.
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 6 : Much better
|
47.6 percentage of participants
|
12.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 12 : Much better
|
50.8 percentage of participants
|
56.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 12 : Somewhat better
|
31.1 percentage of participants
|
18.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 18 : Very much better
|
14.4 percentage of participants
|
31.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 18 : Much better
|
47.5 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 18: Somewhat better
|
36.4 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 24 : Very much better
|
15.4 percentage of participants
|
18.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 24 : Much better
|
53.0 percentage of participants
|
56.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 24 : Somewhat better
|
29.1 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 6 : Very much better
|
15.3 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 6 : Somewhat better
|
34.7 percentage of participants
|
37.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 9 : Very much better
|
11.5 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 9 : Much better
|
50.8 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 9 : Somewhat better
|
36.1 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Feel Better by the Treatment
Month 12 : Very much better
|
13.9 percentage of participants
|
25.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group.
The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 7 was answered on a 4-grade scale: Overall, how satisfied are you with the treatment result? Very satisfied/ Satisfied/ Somewhat satisfied/ Not satisfied.
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 6 : Somewhat satisfied
|
19.4 percentage of participants
|
6.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 6 : Satisfied
|
49.2 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 6 : Very satisfied
|
29.8 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 9 : Somewhat satisfied
|
22.1 percentage of participants
|
12.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 9 : Satisfied
|
55.7 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 9: Very satisfied
|
19.7 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 12: Somewhat satisfied
|
18.9 percentage of participants
|
6.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 12 : Satisfied
|
53.3 percentage of participants
|
37.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 12: Very satisfied
|
23.8 percentage of participants
|
56.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 18: Somewhat satisfied
|
20.3 percentage of participants
|
6.3 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 18 : Satisfied
|
44.1 percentage of participants
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 18: Very satisfied
|
33.1 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 24 : Somewhat satisfied
|
14.5 percentage of participants
|
12.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 24 : Satisfied
|
54.7 percentage of participants
|
37.5 percentage of participants
|
—
|
|
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Month 24 : Very satisfied
|
29.1 percentage of participants
|
50.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group.
The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 8: Did you get any feedback about your look from your family, friends and colleagues? Positive/Negative/No feedback.
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues
Month 6
|
71.0 percentage of participants
|
81.3 percentage of participants
|
—
|
|
Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues
Month 9
|
68.9 percentage of participants
|
81.3 percentage of participants
|
—
|
|
Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues
Month 12
|
77.9 percentage of participants
|
81.3 percentage of participants
|
—
|
|
Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues
Month 18
|
75.4 percentage of participants
|
87.5 percentage of participants
|
—
|
|
Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues
Month 24
|
76.1 percentage of participants
|
93.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group.
The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 9 was a yes or no question: Would you recommend this treatment to friends?
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants Who Recommended This Treatment to Their Friends
Month 6
|
90.3 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Who Recommended This Treatment to Their Friends
Month 9
|
90.2 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Who Recommended This Treatment to Their Friends
Month 12
|
87.7 percentage of participants
|
93.8 percentage of participants
|
—
|
|
Percentage of Participants Who Recommended This Treatment to Their Friends
Month 18
|
89.8 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Who Recommended This Treatment to Their Friends
Month 24
|
90.6 percentage of participants
|
100.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Months 6, 9, 12, 18 and 24Population: FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group.
The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 10 was a yes or no question: Would you like to receive the same treatment again?
Outcome measures
| Measure |
Group B: Sculptra
n=124 Participants
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group A: Sculptra
n=16 Participants
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Percentage of Participants Who Liked to Receive the Same Treatment Again
Month 18: Yes
|
85.6 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Who Liked to Receive the Same Treatment Again
Month 24 : Yes
|
86.3 percentage of participants
|
93.8 percentage of participants
|
—
|
|
Percentage of Participants Who Liked to Receive the Same Treatment Again
Month 6: Yes
|
85.5 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Who Liked to Receive the Same Treatment Again
Month 9: Yes
|
82.8 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants Who Liked to Receive the Same Treatment Again
Month 12 : Yes
|
83.6 percentage of participants
|
93.8 percentage of participants
|
—
|
Adverse Events
Group A: Sculptra
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Group B: Sculptra
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Group B: Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Sculptra
n=16 participants at risk
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Sculptra
n=124 participants at risk
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
n=63 participants at risk
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.00%
0/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Surgical and medical procedures
Basedow's disease
|
0.00%
0/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Cardiac disorders
Cardiac neoplasm unspecific
|
0.00%
0/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
Other adverse events
| Measure |
Group A: Sculptra
n=16 participants at risk
Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Sculptra
n=124 participants at risk
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
|
Group B: Control
n=63 participants at risk
Participants in Group B did not receive any treatment and followed up for 12 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
6.5%
8/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
1/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
General disorders
Implant site nodule
|
0.00%
0/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
5.6%
7/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Cardiac disorders
Arrhythmia
|
12.5%
2/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Eye disorders
Eyelid oedema
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Eye disorders
Xerophthalmia
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
2.4%
3/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Gastrointestinal disorders
Cheilitis
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
2/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
3.2%
2/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Gastrointestinal disorders
Large intestine polyp
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Gastrointestinal disorders
Tooth disorder
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
2/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
General disorders
Asthenia
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
General disorders
Pyrexia
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
2/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Infections and infestations
Conjunctivitis
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
2/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Infections and infestations
Influenza
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Infections and infestations
Pharyngitis
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
4.0%
5/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
1/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Infections and infestations
Respiratory tract infection
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
1/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
4/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
8.1%
10/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
6.3%
4/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
4.0%
5/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
1/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Injury, poisoning and procedural complications
Animal bite
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
1/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Metabolism and nutrition disorders
Calcium deficiency
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
2/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
3.2%
2/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Reproductive system and breast disorders
Cervix disorder
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
2.4%
3/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
3.2%
4/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
1/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
1/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
4.0%
5/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
3.2%
2/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
1/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Vascular disorders
Arteriosclerosis
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.81%
1/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
0.00%
0/124 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
1.6%
1/63 • From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The initial publication of data from the Study must be a multi-center publication. Any subsequent publication/presentation must be sent to Sponsor for review 60 days before submission for publication/presentation to allow Sponsor to protect patentable inventions/confidential information. Site and Investigator agree to amend proposed publication/presentation, remove such confidential information from it, or postpone submission for a further 60 days/until intellectual property filings take place.
- Publication restrictions are in place
Restriction type: OTHER