Trial Outcomes & Findings for Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles (NCT NCT04124692)
NCT ID: NCT04124692
Last Updated: 2023-11-18
Results Overview
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
COMPLETED
NA
149 participants
At Month 12
2023-11-18
Participant Flow
The study was conducted at 13 sites at the United States from 12 November 2019 to12 August 2021.
A total of 149 participants were enrolled and randomized, of which 97 received treatment and 52 received no treatment in this study.
Participant milestones
| Measure |
Control Group: No-treatment
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
97
|
|
Overall Study
COMPLETED
|
46
|
88
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Control Group: No-treatment
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Overall Study
Medical reason
|
0
|
1
|
|
Overall Study
Withdrawal of informed consent (not due to coronavirus disease-19 concerns)
|
2
|
1
|
|
Overall Study
Withdrawal of informed consent (due to coronavirus disease-19 concerns)
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Screen failure due to previous use of Radiesse
|
1
|
0
|
Baseline Characteristics
Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles
Baseline characteristics by cohort
| Measure |
Control Group: No-treatment
n=52 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
n=97 Participants
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 8.72 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 8.50 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type score (FST)
FST I
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type score (FST)
FST II
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type score (FST)
FST III
|
21 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type score (FST)
FST IV
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type score (FST)
FST V
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type score (FST)
FST VI
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
Outcome measures
| Measure |
Control Group: No-treatment
n=46 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
n=88 Participants
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12
|
26.1 percentage of participants
|
71.6 percentage of participants
|
SECONDARY outcome
Timeframe: At Months 7 and 9Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
Outcome measures
| Measure |
Control Group: No-treatment
n=45 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
n=85 Participants
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9
Month 7
|
38.6 percentage of participants
|
66.2 percentage of participants
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9
Month 9
|
31.1 percentage of participants
|
70.6 percentage of participants
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment.
Outcome measures
| Measure |
Control Group: No-treatment
n=46 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
n=88 Participants
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12
Month 7
|
27.3 percentage of participants
|
67.5 percentage of participants
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12
Month 9
|
22.2 percentage of participants
|
64.7 percentage of participants
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12
Month 12
|
28.3 percentage of participants
|
70.5 percentage of participants
|
SECONDARY outcome
Timeframe: At Month 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.
Improvement rate based on the Independent Photographic Reviewer's assessment using random pairings of baseline and Month 12 photographs was done. An improved subject is defined as a subject for whom the Independent Photographic Reviewer identified the month 12 photograph in the pair as post-treatment.
Outcome measures
| Measure |
Control Group: No-treatment
n=44 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
n=84 Participants
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment
Left Cheek
|
29.5 percentage of participants
|
53.6 percentage of participants
|
|
Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment
Right Cheek
|
34.1 percentage of participants
|
57.1 percentage of participants
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.
GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.
Outcome measures
| Measure |
Control Group: No-treatment
n=46 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
n=88 Participants
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
Month 7
|
7.0 percentage of participants
Interval 1.5 to 19.1
|
93.5 percentage of participants
Interval 85.5 to 97.9
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
Month 9
|
6.8 percentage of participants
Interval 1.4 to 18.7
|
89.4 percentage of participants
Interval 80.9 to 95.0
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
Month 12
|
6.5 percentage of participants
Interval 1.4 to 17.9
|
92.0 percentage of participants
Interval 84.3 to 96.7
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.
GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.
Outcome measures
| Measure |
Control Group: No-treatment
n=46 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
n=88 Participants
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment
Month 7
|
6.8 percentage of participants
Interval 1.4 to 18.7
|
96.1 percentage of participants
Interval 89.0 to 99.2
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment
Month 9
|
4.4 percentage of participants
Interval 0.5 to 15.2
|
92.9 percentage of participants
Interval 85.3 to 97.4
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment
Month 12
|
4.3 percentage of participants
Interval 0.5 to 14.8
|
94.3 percentage of participants
Interval 87.2 to 98.1
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 7 · Excellent
|
13 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 7 · Very good
|
24 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 7 · Good
|
15 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 7 · Satisfactory
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 7 · Not satisfied
|
6 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 9 · Excellent
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 9 · Very good
|
26 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 9 · Good
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 9 · Satisfactory
|
15 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 9 · Not satisfied
|
7 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 12 · Excellent
|
15 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 12 · Very good
|
29 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 12 · Good
|
24 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 12 · Satisfactory
|
11 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 12 · Not satisfied
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 7 · Excellent
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 7 · Very Good
|
20 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 7 · Good
|
17 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 7 · Satisfactory
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 7 · Not Satisfied
|
4 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 9 · Excellent
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 9 · Very Good
|
28 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 9 · Good
|
22 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 9 · Satisfactory
|
10 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 9 · Not Satisfied
|
7 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 12 · Excellent
|
21 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 12 · Very Good
|
23 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 12 · Good
|
27 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 12 · Satisfactory
|
11 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 12 · Not Satisfied
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 7 · Excellent
|
14 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 7 · Very good
|
24 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 7 · Good
|
16 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 7 · Satisfactory
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 7 · Not Satisfied
|
5 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 9 · Excellent
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 9 · Very good
|
25 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 9 · Good
|
25 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 9 · Satisfactory
|
9 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 9 · Not Satisfied
|
8 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 12 · Excellent
|
20 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 12 · Very good
|
21 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 12 · Good
|
30 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 12 · Satisfactory
|
10 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 12 · Not Satisfied
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 7 · Excellent
|
17 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 7 · Very Good
|
23 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 7 · Good
|
13 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 7 · Satisfactory
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 7 · Not Satisfied
|
5 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 9 · Excellent
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 9 · Very Good
|
28 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 9 · Good
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 9 · Satisfactory
|
13 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 9 · Not Satisfied
|
7 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 12 · Excellent
|
20 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 12 · Very Good
|
21 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 12 · Good
|
27 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 12 · Satisfactory
|
13 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 12 · Not Satisfied
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 7 · Excellent
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 7 · Very good
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 7 · Good
|
16 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 7 · Satisfactory
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 7 · Not Satisfied
|
5 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 9 · Excellent
|
17 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 9 · Very good
|
26 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 9 · Good
|
21 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 9 · Satisfactory
|
15 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 9 · Not Satisfied
|
6 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 12 · Excellent
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 12 · Very good
|
21 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 12 · Good
|
28 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 12 · Satisfactory
|
13 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 12 · Not Satisfied
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 7 · Excellent
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 7 · Very good
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 7 · Good
|
12 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 7 · Satisfactory
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 7 · Not Satisfied
|
10 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 9 · Excellent
|
21 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 9 · Very good
|
22 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 9 · Good
|
22 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 9 · Satisfactory
|
14 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 9 · Not Satisfied
|
6 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 12 · Excellent
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 12 · Very good
|
20 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 12 · Good
|
25 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 12 · Satisfactory
|
17 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 12 · Not Satisfied
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 7 · Excellent
|
18 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 7 · Very good
|
24 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 7 · Good
|
17 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 7 · Satisfactory
|
13 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 7 · Not Satisfied
|
5 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 9 · Excellent
|
25 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 9 · Very good
|
26 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 9 · Good
|
16 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 9 · Satisfactory
|
11 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 9 · Not Satisfied
|
7 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 12 · Excellent
|
21 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 12 · Very good
|
25 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 12 · Good
|
26 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 12 · Satisfactory
|
11 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 12 · Not Satisfied
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Control Group: No-treatment
n=87 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 7 · Excellent
|
21 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 7 · Very good
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 7 · Good
|
13 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 7 · Satisfactory
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 7 · Not Satisfied
|
5 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 9 · Excellent
|
23 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 9 · Very good
|
26 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 9 · Good
|
13 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 9 · Satisfactory
|
17 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 9 · Not Satisfied
|
6 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 12 · Excellent
|
22 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 12 · Very good
|
23 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 12 · Good
|
24 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 12 · Satisfactory
|
10 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 12 · Not Satisfied
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 7 · Excellent
|
15 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 7 · Very good
|
23 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 7 · Good
|
20 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 7 · Satisfactory
|
7 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 7 · Not Satisfied
|
12 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 9 · Excellent
|
23 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 9 · Very good
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 9 · Good
|
24 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 9 · Satisfactory
|
11 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 9 · Not Satisfied
|
8 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 12 · Excellent
|
20 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 12 · Very good
|
16 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 12 · Good
|
32 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 12 · Satisfactory
|
9 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 12 · Not Satisfied
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 7 · Excellent
|
16 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 7 · Very good
|
23 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 7 · Good
|
19 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 7 · Satisfactory
|
12 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 7 · Not satisfied
|
7 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 9 · Excellent
|
23 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 9 · Very good
|
26 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 9 · Good
|
16 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 9 · Satisfactory
|
14 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 9 · Not satisfied
|
6 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 12 · Excellent
|
23 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 12 · Very good
|
21 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 12 · Good
|
23 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 12 · Satisfactory
|
14 Participants
|
—
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 12 · Not satisfied
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 12 · Strongly Disagree
|
2 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 7 · Strongly agree
|
47 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 7 · Agree
|
25 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 7 · Neither Agree or Disagree
|
4 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 7 · Disagree
|
1 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 7 · Strongly Disagree
|
0 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 9 · Strongly agree
|
48 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 9 · Agree
|
25 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 9 · Neither Agree or Disagree
|
11 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 9 · Disagree
|
0 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 9 · Strongly Disagree
|
1 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 12 · Strongly agree
|
47 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 12 · Agree
|
30 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 12 · Neither Agree or Disagree
|
7 Participants
|
—
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 12 · Disagree
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: At Months 7, 9, and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 7 · Strongly agree
|
36 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 7 · Agree
|
27 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 7 · Neither agree or Disagree
|
11 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 7 · Disagree
|
2 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 7 · Strongly disagree
|
1 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 9 · Strongly agree
|
41 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 9 · Agree
|
27 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 9 · Neither agree or Disagree
|
13 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 9 · Disagree
|
1 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 9 · Strongly disagree
|
3 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 12 · Strongly agree
|
41 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 12 · Agree
|
31 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 12 · Neither agree or Disagree
|
12 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 12 · Disagree
|
2 Participants
|
—
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 12 · Strongly disagree
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: At Month 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A subject satisfaction question with responses Yes or No.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
Yes
|
78 Participants
|
—
|
|
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
No
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: At Month 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluated for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
A subject satisfaction question with responses Yes or No.
Outcome measures
| Measure |
Control Group: No-treatment
n=88 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Subject Satisfaction: Would You do the Treatment Again?
Yes
|
76 Participants
|
—
|
|
Subject Satisfaction: Would You do the Treatment Again?
No
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: Treatment group: Baseline, Months 1, 2, 3, 7, 9 and 12; Control group: Baseline, Months 7, 9 and 12Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.
The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement.
Outcome measures
| Measure |
Control Group: No-treatment
n=45 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
n=94 Participants
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores
At Month 2
|
—
|
31.6 score on a scale
Standard Deviation 28.45
|
|
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores
At Month 1
|
—
|
21.3 score on a scale
Standard Deviation 24.25
|
|
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores
At Month 3
|
—
|
38.6 score on a scale
Standard Deviation 26.51
|
|
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores
At Month 7
|
-4.1 score on a scale
Standard Deviation 20.34
|
38.6 score on a scale
Standard Deviation 26.30
|
|
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores
At Month 9
|
-3.6 score on a scale
Standard Deviation 21.36
|
37.9 score on a scale
Standard Deviation 26.63
|
|
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores
At Month 12
|
-3.6 score on a scale
Standard Deviation 21.76
|
40.0 score on a scale
Standard Deviation 29.07
|
SECONDARY outcome
Timeframe: From start of study drug administration up to end of the study (up to Month 12)Population: Safety population (SP) included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important medical event. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
Control Group: No-treatment
n=52 Participants
Participants received no treatment during the study.
|
Treatment Group: Sculptra Aesthetic
n=97 Participants
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Non-serious AE
|
3 Participants
|
43 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Serious AE
|
0 Participants
|
3 Participants
|
Adverse Events
Control Group: No-treatment
Treatment Group: Sculptra Aesthetic
Serious adverse events
| Measure |
Control Group: No-treatment
n=52 participants at risk
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved.
|
Treatment Group: Sculptra Aesthetic
n=97 participants at risk
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/52 • From start of study drug administration up to end of the study (up to Month 12)
SP included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
|
1.0%
1/97 • From start of study drug administration up to end of the study (up to Month 12)
SP included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/52 • From start of study drug administration up to end of the study (up to Month 12)
SP included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
|
1.0%
1/97 • From start of study drug administration up to end of the study (up to Month 12)
SP included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
|
|
Gastrointestinal disorders
Obstruction gastric and small intestine adenocarcinoma
|
0.00%
0/52 • From start of study drug administration up to end of the study (up to Month 12)
SP included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
|
1.0%
1/97 • From start of study drug administration up to end of the study (up to Month 12)
SP included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
|
Other adverse events
| Measure |
Control Group: No-treatment
n=52 participants at risk
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved.
|
Treatment Group: Sculptra Aesthetic
n=97 participants at risk
Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved.
|
|---|---|---|
|
General disorders
Injection site bruising
|
0.00%
0/52 • From start of study drug administration up to end of the study (up to Month 12)
SP included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
|
11.3%
11/97 • From start of study drug administration up to end of the study (up to Month 12)
SP included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER