Trial Outcomes & Findings for Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds. (NCT NCT03780244)
NCT ID: NCT03780244
Last Updated: 2022-11-14
Results Overview
The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
48 weeks
Results posted on
2022-11-14
Participant Flow
Participant milestones
| Measure |
Investigational Study Product
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
21
|
|
Overall Study
COMPLETED
|
58
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Investigational Study Product
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
Baseline characteristics by cohort
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 9.93 • n=7 Participants
|
51.5 years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
62 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
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
21 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST I
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST II
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST III
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST IV
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST V
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST VI
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksThe WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Change in Wrinkle Assessment Scale (WAS) Score
Left NLF
|
-1.3 units on a scale
Interval -1.6 to -1.1
|
-1.3 units on a scale
Interval -1.8 to -0.8
|
|
Change in Wrinkle Assessment Scale (WAS) Score
Right NLF
|
-1.2 units on a scale
Interval -1.4 to -1.0
|
-1.3 units on a scale
Interval -1.8 to -0.9
|
SECONDARY outcome
Timeframe: Weeks 16, 24, 32, and 40Population: Intent-to-Treat Population, Observed cases
The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face as assessed by the Blinded Evaluator using WAS at X weeks
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Change in Wrinkle Assessment Scale (WAS) Score
Week 16- Left NLF
|
-1.3 units on a scale
Standard Deviation 0.96
|
-1.5 units on a scale
Standard Deviation 0.81
|
|
Change in Wrinkle Assessment Scale (WAS) Score
Week 16- Right NLF
|
-1.1 units on a scale
Standard Deviation 0.69
|
-1.5 units on a scale
Standard Deviation 0.60
|
|
Change in Wrinkle Assessment Scale (WAS) Score
Week 24- Left NLF
|
-1.2 units on a scale
Standard Deviation 0.94
|
-1.4 units on a scale
Standard Deviation 1.21
|
|
Change in Wrinkle Assessment Scale (WAS) Score
Week 24- Right NFL
|
-1.1 units on a scale
Standard Deviation 0.84
|
-1.5 units on a scale
Standard Deviation 0.68
|
|
Change in Wrinkle Assessment Scale (WAS) Score
Week 32- Left NLF
|
-1.2 units on a scale
Standard Deviation 1.00
|
-1.2 units on a scale
Standard Deviation 0.93
|
|
Change in Wrinkle Assessment Scale (WAS) Score
Week 32- Right NLF
|
-1.1 units on a scale
Standard Deviation 0.86
|
-1.3 units on a scale
Standard Deviation 0.97
|
|
Change in Wrinkle Assessment Scale (WAS) Score
Week 40- Left NLF
|
-1.3 units on a scale
Standard Deviation 0.94
|
-1.4 units on a scale
Standard Deviation 0.86
|
|
Change in Wrinkle Assessment Scale (WAS) Score
Week 40- Right NLF
|
-1.2 units on a scale
Standard Deviation 0.78
|
-1.4 units on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Weeks 16, 24, 32, 40, and 48.Population: Intent-to-Treat Population, observed cases
Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the subject
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment
Week 16
|
54 Participants
|
20 Participants
|
|
Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment
Week 24
|
53 Participants
|
20 Participants
|
|
Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment
Week 32
|
52 Participants
|
20 Participants
|
|
Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment
Week 40
|
51 Participants
|
20 Participants
|
|
Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment
Week 48
|
51 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Weeks 16, 24, 32, 40 and 48Population: Intent-to-Treat Population, Observed cases
Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the Treating Investigator
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment
Week 16
|
56 Participants
|
21 Participants
|
|
Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment
Week 24
|
58 Participants
|
21 Participants
|
|
Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment
Week 32
|
57 Participants
|
21 Participants
|
|
Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment
Week 40
|
59 Participants
|
21 Participants
|
|
Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment
Week 48
|
57 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline and at weeks 24, 32, 40 and 48Population: Intent-to-Treat Population, Observed cases
Subjects' satisfaction using the validated FACE-Q Scale, Rasch-transformed total score (0-100) according to the FACE-Q manual; the higher total score indicated greater subject satisfaction
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Baseline
|
37.8 score on a scale
Standard Deviation 20.89
|
39.4 score on a scale
Standard Deviation 16.22
|
|
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Week 24
|
75.3 score on a scale
Standard Deviation 23.10
|
81.2 score on a scale
Standard Deviation 19.83
|
|
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Week 32
|
72.4 score on a scale
Standard Deviation 24.44
|
73.2 score on a scale
Standard Deviation 23.80
|
|
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Week 40
|
71.3 score on a scale
Standard Deviation 25.31
|
77.2 score on a scale
Standard Deviation 21.33
|
|
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Week 48
|
74.3 score on a scale
Standard Deviation 23.60
|
79.9 score on a scale
Standard Deviation 19.39
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 16 · Very Satisfied
|
29 Participants
|
11 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 16 · Satisfied
|
19 Participants
|
10 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 16 · Neutral (not satisfied or dissatisfied)
|
6 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 16 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 16 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 24 · Very Satisfied
|
22 Participants
|
8 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 24 · Satisfied
|
28 Participants
|
12 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 24 · Neutral (not satisfied or dissatisfied)
|
6 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 24 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 24 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 32 · Very Satisfied
|
25 Participants
|
10 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 32 · Satisfied
|
18 Participants
|
9 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 32 · Neutral (not satisfied or dissatisfied)
|
12 Participants
|
2 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 32 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 32 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 40 · Very Satisfied
|
24 Participants
|
11 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 40 · Satisfied
|
26 Participants
|
7 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 40 · Neutral (not satisfied or dissatisfied)
|
6 Participants
|
3 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 40 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 40 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 48 · Very Satisfied
|
23 Participants
|
10 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 48 · Satisfied
|
25 Participants
|
9 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 48 · Neutral (not satisfied or dissatisfied)
|
7 Participants
|
2 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 48 · Dissatisfied
|
3 Participants
|
0 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Week 48 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 16 · Very satisfied
|
21 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 16 · Satisfied
|
23 Participants
|
12 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 16 · Neutral (not satisfied or dissatisfied)
|
10 Participants
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 16 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 16 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 24 · Very satisfied
|
19 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 24 · Satisfied
|
25 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 24 · Neutral (not satisfied or dissatisfied)
|
12 Participants
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 24 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 24 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 32 · Very satisfied
|
25 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 32 · Satisfied
|
17 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 32 · Neutral (not satisfied or dissatisfied)
|
13 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 32 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 32 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 40 · Very satisfied
|
24 Participants
|
11 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 40 · Satisfied
|
23 Participants
|
6 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 40 · Neutral (not satisfied or dissatisfied)
|
9 Participants
|
4 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 40 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 40 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 48 · Very satisfied
|
20 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 48 · Satisfied
|
24 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 48 · Neutral (not satisfied or dissatisfied)
|
11 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 48 · Dissatisfied
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Week 48 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 32 · Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 16 · Very Satisfied
|
24 Participants
|
11 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 16 · Satisfied
|
19 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 16 · Neutral (not satisfied or dissatisfied)
|
11 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 16 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 16 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 24 · Very Satisfied
|
21 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 24 · Satisfied
|
28 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 24 · Neutral (not satisfied or dissatisfied)
|
6 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 24 · Dissatisfied
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 24 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 32 · Very Satisfied
|
27 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 32 · Satisfied
|
17 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 32 · Neutral (not satisfied or dissatisfied)
|
12 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 32 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 40 · Very Satisfied
|
24 Participants
|
13 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 40 · Satisfied
|
21 Participants
|
4 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 40 · Neutral (not satisfied or dissatisfied)
|
11 Participants
|
4 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 40 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 40 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 48 · Very Satisfied
|
24 Participants
|
11 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 48 · Satisfied
|
23 Participants
|
7 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 48 · Neutral (not satisfied or dissatisfied)
|
9 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 48 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Week 48 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 16 · Very Satisfied
|
21 Participants
|
7 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 16 · Satisfied
|
19 Participants
|
12 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 16 · Neutral (not satisfied or dissatisfied)
|
15 Participants
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 16 · Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 16 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 24 · Very Satisfied
|
18 Participants
|
7 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 24 · Satisfied
|
24 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 24 · Neutral (not satisfied or dissatisfied)
|
13 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 24 · Dissatisfied
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 24 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 32 · Very Satisfied
|
24 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 32 · Satisfied
|
17 Participants
|
7 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 32 · Neutral (not satisfied or dissatisfied)
|
14 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 32 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 32 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 40 · Very Satisfied
|
22 Participants
|
11 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 40 · Satisfied
|
20 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 40 · Neutral (not satisfied or dissatisfied)
|
14 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 40 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 40 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 48 · Very Satisfied
|
22 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 48 · Satisfied
|
19 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 48 · Neutral (not satisfied or dissatisfied)
|
15 Participants
|
4 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 48 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Week 48 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 16 · Very Satisfied
|
23 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 16 · Satisfied
|
26 Participants
|
12 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 16 · Neutral
|
6 Participants
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 16 · Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 16 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 24 · Very Satisfied
|
17 Participants
|
7 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 24 · Satisfied
|
34 Participants
|
13 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 24 · Neutral
|
5 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 24 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 24 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 32 · Very Satisfied
|
24 Participants
|
12 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 32 · Satisfied
|
22 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 32 · Neutral
|
10 Participants
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 32 · Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 32 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 40 · Very Satisfied
|
23 Participants
|
12 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 40 · Satisfied
|
26 Participants
|
6 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 40 · Neutral
|
7 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 40 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 40 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 48 · Very Satisfied
|
25 Participants
|
11 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 48 · Satisfied
|
20 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 48 · Neutral
|
11 Participants
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 48 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Week 48 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 16 · Very Satisfied
|
16 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 16 · Satisfied
|
23 Participants
|
11 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 16 · Neutral (not satisfied or dissatisfied)
|
15 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 16 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 16 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 24 · Very Satisfied
|
16 Participants
|
6 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 24 · Satisfied
|
25 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 24 · Neutral (not satisfied or dissatisfied)
|
15 Participants
|
6 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 24 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 24 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 32 · Very Satisfied
|
21 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 32 · Satisfied
|
16 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 32 · Neutral (not satisfied or dissatisfied)
|
18 Participants
|
4 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 32 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 32 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 40 · Very Satisfied
|
21 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 40 · Satisfied
|
21 Participants
|
7 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 40 · Neutral (not satisfied or dissatisfied)
|
14 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 40 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 40 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 48 · Very Satisfied
|
21 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 48 · Satisfied
|
20 Participants
|
6 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 48 · Neutral (not satisfied or dissatisfied)
|
15 Participants
|
6 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 48 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Week 48 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 16 · Very Satisfied
|
16 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 16 · Satisfied
|
25 Participants
|
13 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 16 · Neutral (not satisfied or dissatisfied)
|
14 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 16 · Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 16 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 24 · Very Satisfied
|
16 Participants
|
7 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 24 · Satisfied
|
30 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 24 · Neutral (not satisfied or dissatisfied)
|
10 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 24 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 24 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 32 · Very Satisfied
|
21 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 32 · Satisfied
|
19 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 32 · Neutral (not satisfied or dissatisfied)
|
14 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 32 · Dissatisfied
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 32 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 40 · Very Satisfied
|
22 Participants
|
11 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 40 · Satisfied
|
21 Participants
|
6 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 40 · Neutral (not satisfied or dissatisfied)
|
12 Participants
|
4 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 40 · Dissatisfied
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 40 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 48 · Very Satisfied
|
19 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 48 · Satisfied
|
21 Participants
|
4 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 48 · Neutral (not satisfied or dissatisfied)
|
16 Participants
|
7 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 48 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Week 48 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 16 · Very Satisfied
|
24 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 16 · Satisfied
|
21 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 16 · Neutral (not satisfied or dissatisfied)
|
9 Participants
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 16 · Dissatisfied
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 16 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 24 · Very Satisfied
|
17 Participants
|
7 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 24 · Satisfied
|
27 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 24 · Neutral (not satisfied or dissatisfied)
|
11 Participants
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 24 · Dissatisfied
|
3 Participants
|
1 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 24 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 32 · Very Satisfied
|
22 Participants
|
11 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 32 · Satisfied
|
20 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 32 · Neutral (not satisfied or dissatisfied)
|
11 Participants
|
2 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 32 · Dissatisfied
|
4 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 32 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 40 · Very Satisfied
|
22 Participants
|
10 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 40 · Satisfied
|
26 Participants
|
8 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 40 · Neutral (not satisfied or dissatisfied)
|
7 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 40 · Dissatisfied
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 40 · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 48 · Very Satisfied
|
20 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 48 · Satisfied
|
24 Participants
|
9 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 48 · Neutral (not satisfied or dissatisfied)
|
11 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 48 · Dissatisfied
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Week 48 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 48 · Disagree
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 48 · Strongly Disagree
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 16 · Strongly Agree
|
37 Participants
|
17 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 16 · Agree
|
14 Participants
|
4 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 16 · Neither agree or disagree
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 16 · Disagree
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 16 · Strongly Disagree
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 24 · Strongly Agree
|
34 Participants
|
14 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 24 · Agree
|
16 Participants
|
6 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 24 · Neither agree or disagree
|
4 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 24 · Disagree
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 24 · Strongly Disagree
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 32 · Strongly Agree
|
31 Participants
|
15 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 32 · Agree
|
15 Participants
|
6 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 32 · Neither agree or disagree
|
7 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 32 · Disagree
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 32 · Strongly Disagree
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 40 · Strongly Agree
|
31 Participants
|
13 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 40 · Agree
|
16 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 40 · Neither agree or disagree
|
8 Participants
|
2 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 40 · Disagree
|
1 Participants
|
1 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 40 · Strongly Disagree
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 48 · Strongly Agree
|
31 Participants
|
15 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 48 · Agree
|
15 Participants
|
4 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Week 48 · Neither agree or disagree
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 16 · Strongly Agree
|
38 Participants
|
17 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 40 · Strongly Agree
|
39 Participants
|
14 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 40 · Agree
|
15 Participants
|
7 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 40 · Neither agree or disagree
|
4 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 40 · Disagree
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 40 · Strong Disagree
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 48 · Strongly Agree
|
36 Participants
|
15 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 48 · Agree
|
18 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 48 · Neither agree or disagree
|
3 Participants
|
1 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 48 · Disagree
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 48 · Strong Disagree
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 16 · Agree
|
16 Participants
|
4 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 16 · Neither agree or disagree
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 16 · Disagree
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 16 · Strong Disagree
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 24 · Strongly Agree
|
38 Participants
|
15 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 24 · Agree
|
17 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 24 · Neither agree or disagree
|
2 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 24 · Disagree
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 24 · Strong Disagree
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 32 · Strongly Agree
|
38 Participants
|
15 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 32 · Agree
|
16 Participants
|
6 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 32 · Neither agree or disagree
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 32 · Disagree
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Week 32 · Strong Disagree
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A subject satisfaction question with responses Yes or No.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 16 · Yes
|
53 Participants
|
19 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 16 · No
|
4 Participants
|
2 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 24 · Yes
|
54 Participants
|
17 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 24 · No
|
4 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 32 · Yes
|
50 Participants
|
18 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 32 · No
|
7 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 40 · Yes
|
48 Participants
|
18 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 40 · No
|
11 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 48 · Yes
|
52 Participants
|
17 Participants
|
|
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Week 48 · No
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 16, 24, 32, 40 and 48Population: ITT- observed cases
A subject satisfaction question with responses Yes or No.
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 16 · Yes
|
52 Participants
|
21 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 16 · No
|
5 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 24 · Yes
|
53 Participants
|
20 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 24 · No
|
5 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 32 · Yes
|
48 Participants
|
20 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 32 · No
|
9 Participants
|
1 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 40 · Yes
|
51 Participants
|
19 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 40 · No
|
8 Participants
|
2 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 48 · Yes
|
50 Participants
|
19 Participants
|
|
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Week 48 · No
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12Population: Intent-to-Treat Population
Subjects were asked to complete the following questions in the subject diary: * Did you feel comfortable to return to social engagement today? (Yes or No) * If yes, what was the earliest time you felt comfortable to return to social engagement? (Record date and time \[using 24-hour clock\])
Outcome measures
| Measure |
Investigational Study Product
n=59 Participants
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 Participants
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting
After treatment 1
|
1.4 time in hours
Interval 0.6 to 3.8
|
2 time in hours
Interval 0.8 to 3.8
|
|
Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting
After treatment 2
|
1.6 time in hours
Interval 0.9 to 4.6
|
1 time in hours
Interval 0.7 to 3.1
|
|
Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting
After treatment 3
|
1.5 time in hours
Interval 0.8 to 4.2
|
1.5 time in hours
Interval 0.9 to 7.9
|
|
Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting
After treatment 4
|
1.5 time in hours
Interval 0.9 to 3.4
|
1.0 time in hours
Interval 0.8 to 3.5
|
Adverse Events
Investigational Study Product
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Reference Product
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational Study Product
n=59 participants at risk
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 participants at risk
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Eye disorders
Retinal detachment
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
Other adverse events
| Measure |
Investigational Study Product
n=59 participants at risk
Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds
|
Reference Product
n=21 participants at risk
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
|
|---|---|---|
|
Gastrointestinal disorders
Hypoesthesia oral
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
|
Gastrointestinal disorders
Oral disorder
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
|
General disorders
Injection site hypoaesthesia
|
1.7%
1/59 • Number of events 6 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
|
General disorders
Injection site paraesthesia
|
1.7%
1/59 • Number of events 4 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
|
General disorders
Injection site induration
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
|
General disorders
Injection site nodule
|
0.00%
0/59 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
|
General disorders
Injection site pain
|
0.00%
0/59 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
|
General disorders
Swelling
|
0.00%
0/59 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
|
Infections and infestations
Herpes simplex
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
|
Infections and infestations
Oral herpes
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/59 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
|
Nervous system disorders
Headache
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
9.5%
2/21 • Number of events 3 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/59 • 48 weeks
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/59 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/59 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites
- Publication restrictions are in place
Restriction type: OTHER