Trial Outcomes & Findings for Clinical Study for the Evaluation of the Safety and Effectiveness of Use of a Poly-L Lactic Acid Injectable Filler for the Aesthetic Treatment of Nasolabial Folds (NCT NCT05215054)
NCT ID: NCT05215054
Last Updated: 2025-01-20
Results Overview
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Change of grades was calculated as the value at 6 months minus the value at baseline. To observe an improvement of the nasolabial folds wrinkles, a decrease of the mean score was expected.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2025-01-20
Participant Flow
The clinical investigation was initiated on 7 March 2022 (first subject first visit). Subjects were recruited from one investigational center, Eurofins Dermscan Pharmascan centre in Villeurbanne, France.The last subject was screened on 4 May 2022, and the recruitment period lasted 58 days.
4 subjects were enrolled but not randomized in the study due to consent withdrawal or because they were lost to follow-up
Unit of analysis: Nasolabial fold
Participant milestones
| Measure |
Gana V
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
Participants received Sculptra in the other nasolabial fold (as per randomization list-split face design). 1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
|---|---|---|
|
Overall Study
STARTED
|
55 55
|
55 55
|
|
Overall Study
COMPLETED
|
49 49
|
49 49
|
|
Overall Study
NOT COMPLETED
|
6 6
|
6 6
|
Reasons for withdrawal
| Measure |
Gana V
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
Participants received Sculptra in the other nasolabial fold (as per randomization list-split face design). 1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Gana V Versus Sculptra
n=55 Participants
Participants received both Gana V and Sculptra: one in each nasolabial folds
|
|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 8.7 • n=55 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=55 Participants
|
|
Region of Enrollment
France
|
55 participants
n=55 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value.
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Change of grades was calculated as the value at 6 months minus the value at baseline. To observe an improvement of the nasolabial folds wrinkles, a decrease of the mean score was expected.
Outcome measures
| Measure |
Gana V
n=53 Nasolabial fold
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
n=53 Nasolabial fold
Participants received Sculptra in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Gana V Versus Sculptra
n=106 Nasolabial fold
Comparison between results obtained for Gana V and results obtained for Sculptra
|
|---|---|---|---|
|
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment
|
-0.3 score on a scale
Interval -0.4 to -0.1
|
-0.2 score on a scale
Interval -0.3 to -0.1
|
-0.1 score on a scale
Interval -0.2 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value.
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Change of grades was calculated as the value at month X minus the value at baseline. To observe an improvement of the nasolabial folds wrinkles, a decrease of the mean score was expected.
Outcome measures
| Measure |
Gana V
n=110 Nasolabial fold
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
n=55 Nasolabial fold
Participants received Sculptra in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Gana V Versus Sculptra
n=55 Nasolabial fold
Comparison between results obtained for Gana V and results obtained for Sculptra
|
|---|---|---|---|
|
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
Change from baseline (D0 visit) to M11/2 visit
|
-0.1 score on a scale
Standard Deviation 0.3
|
-0.1 score on a scale
Standard Deviation 0.3
|
-0.0 score on a scale
Standard Deviation 0.2
|
|
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
Change from baseline (D0 visit) to M3 visit
|
0.0 score on a scale
Standard Deviation 0.2
|
-0.1 score on a scale
Standard Deviation 0.3
|
-0.1 score on a scale
Standard Deviation 0.3
|
|
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
Change from baseline (D0 visit) to M6 visit
|
-0.1 score on a scale
Standard Deviation 0.5
|
-0.3 score on a scale
Standard Deviation 0.4
|
-0.2 score on a scale
Standard Deviation 0.4
|
|
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
Change from baseline (D0 0visit) to M9 visit
|
-0.2 score on a scale
Standard Deviation 0.6
|
-0.4 score on a scale
Standard Deviation 0.5
|
-0.3 score on a scale
Standard Deviation 0.4
|
|
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
Change from baseline (D0 visit) to M12 visit
|
-0.1 score on a scale
Standard Deviation 0.5
|
-0.4 score on a scale
Standard Deviation 0.6
|
-0.3 score on a scale
Standard Deviation 0.5
|
|
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
Change from baseline (D0 visit) to M18 visit
|
-0.1 score on a scale
Standard Deviation 0.3
|
-0.3 score on a scale
Standard Deviation 0.5
|
-0.2 score on a scale
Standard Deviation 0.5
|
|
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
Change from baseline (D0 visit) to M24 visit
|
-0.1 score on a scale
Standard Deviation 0.3
|
-0.2 score on a scale
Standard Deviation 0.5
|
-0.1 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value.
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Responders rate = percentage of participants with an improvement of at least one grade in WSRS compared to baseline score. An improvement represents a decrease in WSRS (from grade 5 to grade 4 for instance)
Outcome measures
| Measure |
Gana V
n=55 Participants
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
n=55 Participants
Participants received Sculptra in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Gana V Versus Sculptra
Comparison between results obtained for Gana V and results obtained for Sculptra
|
|---|---|---|---|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M11/2 visit · Responder
|
5 Participants
|
2 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M11/2 visit · Not responder
|
50 Participants
|
53 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M3 visit · Responder
|
6 Participants
|
6 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M3 visit · Not responder
|
43 Participants
|
43 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M6 visit · Responder
|
14 Participants
|
11 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M6 visit · Not responder
|
39 Participants
|
42 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M9 visit · Responder
|
20 Participants
|
13 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M9 visit · Not responder
|
28 Participants
|
35 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M12 visit · Responder
|
16 Participants
|
13 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M12 visit · Not responder
|
31 Participants
|
34 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M18 visit · Responder
|
12 Participants
|
9 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M18 visit · Not responder
|
37 Participants
|
40 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M24 visit · Responder
|
10 Participants
|
6 Participants
|
—
|
|
WSRS Responders Rate
Responder rate from baseline (D0 visit) to M24 visit · Not responder
|
39 Participants
|
43 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value.
Percentage of participants with an improvement on GAIS. A responder is defined as a subject having "Improved", "Much improved" or "Very much improved" score according to GAIS.
Outcome measures
| Measure |
Gana V
n=55 Participants
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
n=55 Participants
Participants received Sculptra in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Gana V Versus Sculptra
Comparison between results obtained for Gana V and results obtained for Sculptra
|
|---|---|---|---|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M11/2 · Responder
|
20 Participants
|
18 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M11/2 · Not responder
|
35 Participants
|
37 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M3 · Responder
|
21 Participants
|
17 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M3 · Not responder
|
28 Participants
|
32 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M6 · Responder
|
38 Participants
|
29 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M6 · Not responder
|
15 Participants
|
24 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M9 · Responder
|
32 Participants
|
31 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M9 · Not responder
|
16 Participants
|
17 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M12 · Responder
|
30 Participants
|
28 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M12 · Not responder
|
16 Participants
|
18 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M18 · Responder
|
26 Participants
|
27 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M18 · Not responder
|
23 Participants
|
22 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M24 · Responder
|
16 Participants
|
17 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M24 · Not responder
|
33 Participants
|
32 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M11/2 · Responder
|
27 Participants
|
27 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M11/2 · Not responder
|
28 Participants
|
28 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M3 · Responder
|
34 Participants
|
32 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M3 · Not responder
|
19 Participants
|
21 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M6 · Responder
|
35 Participants
|
34 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M6 · Not responder
|
18 Participants
|
19 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M9 · Responder
|
32 Participants
|
28 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M9 · Not responder
|
15 Participants
|
20 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M12 · Responder
|
29 Participants
|
28 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M12 · Not responder
|
18 Participants
|
19 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M18 · Responder
|
29 Participants
|
31 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M18 · Not responder
|
20 Participants
|
18 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M24 · Responder
|
21 Participants
|
24 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subjects at M24 · Not responder
|
28 Participants
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value.
The average depth of the nasolabial folds wrinkles was calculated using a fringe projection system. An increase of the mean value means a positive outcome. Change was calculated as the value at each follow-up visit minus the value at baseline
Outcome measures
| Measure |
Gana V
n=110 Nasolabial fold
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
n=55 Nasolabial fold
Participants received Sculptra in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Gana V Versus Sculptra
n=55 Nasolabial fold
Comparison between results obtained for Gana V and results obtained for Sculptra
|
|---|---|---|---|
|
Change From Baseline in Nasolabial Folds Average Depth (mm)
Change from baseline (D0 visit) to M11/2 visit
|
0.004 mm
Standard Deviation 0.019
|
0.018 mm
Standard Deviation 0.017
|
0.014 mm
Standard Deviation 0.016
|
|
Change From Baseline in Nasolabial Folds Average Depth (mm)
Change from baseline (D0 visit) to M3 visit
|
0.008 mm
Standard Deviation 0.022
|
0.029 mm
Standard Deviation 0.025
|
0.021 mm
Standard Deviation 0.017
|
|
Change From Baseline in Nasolabial Folds Average Depth (mm)
Change from baseline (D0 visit) to M6 visit
|
0.005 mm
Standard Deviation 0.026
|
0.029 mm
Standard Deviation 0.028
|
0.024 mm
Standard Deviation 0.021
|
|
Change From Baseline in Nasolabial Folds Average Depth (mm)
Change from baseline (D0 visit) to M9 visit
|
0.008 mm
Standard Deviation 0.024
|
0.031 mm
Standard Deviation 0.028
|
0.023 mm
Standard Deviation 0.021
|
|
Change From Baseline in Nasolabial Folds Average Depth (mm)
Change from baseline (D0 visit) to M12 visit
|
0.008 mm
Standard Deviation 0.027
|
0.029 mm
Standard Deviation 0.030
|
0.021 mm
Standard Deviation 0.020
|
|
Change From Baseline in Nasolabial Folds Average Depth (mm)
Change from baseline (D0 visit) to M18 visit
|
0.008 mm
Standard Deviation 0.034
|
0.029 mm
Standard Deviation 0.027
|
0.020 mm
Standard Deviation 0.027
|
|
Change From Baseline in Nasolabial Folds Average Depth (mm)
Change from baseline (D0 visit) to M24 visit
|
-0.002 mm
Standard Deviation 0.033
|
0.016 mm
Standard Deviation 0.022
|
0.016 mm
Standard Deviation 0.031
|
SECONDARY outcome
Timeframe: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value
The volume of the nasolabial folds wrinkles was calculated using a fringe projection system. A decrease of the volume means a positive outcome.
Outcome measures
| Measure |
Gana V
n=110 Nasolabial fold
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
n=55 Nasolabial fold
Participants received Sculptra in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Gana V Versus Sculptra
n=55 Nasolabial fold
Comparison between results obtained for Gana V and results obtained for Sculptra
|
|---|---|---|---|
|
Change From Baseline in Nasolabial Folds Volume
Change from baseline (D0 visit) to M11/2 visit
|
-0.606 mm3
Standard Deviation 1.707
|
-1.444 mm3
Standard Deviation 1.692
|
-0.838 mm3
Standard Deviation 1.408
|
|
Change From Baseline in Nasolabial Folds Volume
Change from baseline (D0 visit) to M3 visit
|
-0.840 mm3
Standard Deviation 1.914
|
-2.458 mm3
Standard Deviation 2.271
|
-1.619 mm3
Standard Deviation 1.938
|
|
Change From Baseline in Nasolabial Folds Volume
Change from baseline (D0 visit) to M6 visit
|
-0.782 mm3
Standard Deviation 1.918
|
-2.591 mm3
Standard Deviation 2.038
|
-1.809 mm3
Standard Deviation 1.709
|
|
Change From Baseline in Nasolabial Folds Volume
Change from baseline (D0 visit) to M9 visit
|
-1.041 mm3
Standard Deviation 1.919
|
-2.719 mm3
Standard Deviation 2.059
|
-1.677 mm3
Standard Deviation 1.956
|
|
Change From Baseline in Nasolabial Folds Volume
Change from baseline (D0 visit) to M12 visit
|
-0.832 mm3
Standard Deviation 1.985
|
-2.281 mm3
Standard Deviation 2.232
|
-1.449 mm3
Standard Deviation 1.707
|
|
Change From Baseline in Nasolabial Folds Volume
Change from baseline (D0 visit) to M18 visit
|
-0.909 mm3
Standard Deviation 2.383
|
-2.351 mm3
Standard Deviation 2.305
|
-1.442 mm3
Standard Deviation 2.162
|
|
Change From Baseline in Nasolabial Folds Volume
Change from baseline (D0 visit) to M24 visit
|
0.161 mm3
Standard Deviation 2.392
|
-0.949 mm3
Standard Deviation 2.031
|
-0.939 mm3
Standard Deviation 2.496
|
SECONDARY outcome
Timeframe: Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value
Percentage of participants with positive answers to an internal questionnaire
Outcome measures
| Measure |
Gana V
n=55 Participants
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
n=55 Participants
Participants received Sculptra in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Gana V Versus Sculptra
Comparison between results obtained for Gana V and results obtained for Sculptra
|
|---|---|---|---|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M6 · Satisfied
|
37 Participants
|
36 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M6 · Not satisfied
|
16 Participants
|
17 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M9 · Satisfied
|
31 Participants
|
29 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M9 · Not satisfied
|
17 Participants
|
19 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M12 · Satisfied
|
36 Participants
|
34 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M12 · Not satisfied
|
11 Participants
|
13 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M18 · Satisfied
|
32 Participants
|
30 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M18 · Not satisfied
|
17 Participants
|
19 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M24 · Satisfied
|
28 Participants
|
27 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M24 · Not satisfied
|
21 Participants
|
22 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M11/2 · Satisfied
|
37 Participants
|
37 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M11/2 · Not satisfied
|
18 Participants
|
18 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M3 · Satisfied
|
40 Participants
|
37 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M3 · Not satisfied
|
13 Participants
|
16 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M6 · Satisfied
|
41 Participants
|
40 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M6 · Not satisfied
|
12 Participants
|
13 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M9 · Satisfied
|
37 Participants
|
34 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M9 · Not satisfied
|
11 Participants
|
14 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M12 · Satisfied
|
37 Participants
|
36 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M12 · Not satisfied
|
10 Participants
|
11 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M18 · Satisfied
|
35 Participants
|
35 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M18 · Not satisfied
|
14 Participants
|
14 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M24 · Satisfied
|
32 Participants
|
30 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is natural at M24 · Not satisfied
|
16 Participants
|
19 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M11/2 · Satisfied
|
24 Participants
|
25 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M11/2 · Not satisfied
|
31 Participants
|
30 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M3 · Satisfied
|
30 Participants
|
30 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M3 · Not satisfied
|
22 Participants
|
22 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M6 · Satisfied
|
31 Participants
|
34 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M6 · Not satisfied
|
22 Participants
|
19 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M9 · Satisfied
|
28 Participants
|
27 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M9 · Not satisfied
|
20 Participants
|
21 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M12 · Satisfied
|
30 Participants
|
28 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M12 · Not satisfied
|
17 Participants
|
19 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M18 · Satisfied
|
27 Participants
|
28 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M18 · Not satisfied
|
22 Participants
|
21 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M24 · Satisfied
|
22 Participants
|
21 Participants
|
—
|
|
Proportion of Satisfied Participants
The facial volumes are restored at M24 · Not satisfied
|
27 Participants
|
28 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M11/2 · Satisfied
|
26 Participants
|
27 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M11/2 · Not satisfied
|
29 Participants
|
28 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M3 · Satisfied
|
32 Participants
|
32 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M3 · Not satisfied
|
21 Participants
|
21 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M6 · Satisfied
|
35 Participants
|
35 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M6 · Not satisfied
|
18 Participants
|
18 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M9 · Satisfied
|
31 Participants
|
29 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M9 · Not satisfied
|
16 Participants
|
19 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M12 · Satisfied
|
32 Participants
|
30 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M12 · Not satisfied
|
15 Participants
|
17 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M18 · Satisfied
|
28 Participants
|
29 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M18 · Not satisfied
|
20 Participants
|
20 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M24 · Satisfied
|
25 Participants
|
25 Participants
|
—
|
|
Proportion of Satisfied Participants
My features seem rested at M24 · Not satisfied
|
24 Participants
|
24 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M11/2 · Satisfied
|
28 Participants
|
29 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M11/2 · Not satisfied
|
27 Participants
|
26 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M3 · Satisfied
|
34 Participants
|
33 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M3 · Not satisfied
|
19 Participants
|
20 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M6 · Satisfied
|
38 Participants
|
37 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M6 · Not satisfied
|
15 Participants
|
16 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M9 · Satisfied
|
32 Participants
|
29 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M9 · Not satisfied
|
16 Participants
|
19 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M12 · Satisfied
|
34 Participants
|
33 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M12 · Not satisfied
|
13 Participants
|
14 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M18 · Satisfied
|
32 Participants
|
29 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M18 · Not satisfied
|
17 Participants
|
20 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M24 · Satisfied
|
25 Participants
|
24 Participants
|
—
|
|
Proportion of Satisfied Participants
Are you satisfied with how your nasolabial fold looks? at M24 · Not satisfied
|
24 Participants
|
25 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M11/2 · Satisfied
|
29 Participants
|
28 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M11/2 · Not satisfied
|
26 Participants
|
27 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M3 · Satisfied
|
31 Participants
|
30 Participants
|
—
|
|
Proportion of Satisfied Participants
The result is aesthetically satisfying at M3 · Not satisfied
|
21 Participants
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: After initial injection (Day 0) and touch-up if applicable (Month 1^1/2)Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value
Percentage of participants
Outcome measures
| Measure |
Gana V
n=55 Participants
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
n=55 Participants
Participants received Sculptra in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Gana V Versus Sculptra
Comparison between results obtained for Gana V and results obtained for Sculptra
|
|---|---|---|---|
|
Injector Satisfaction
Ease of injection after initial injection · Very satisfied
|
32 Participants
|
29 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after initial injection · Satisfied
|
18 Participants
|
21 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after initial injection · Somewhat satisfied
|
5 Participants
|
5 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after initial injection · Somewhat dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after initial injection · Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after initial injection · Very dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after touch-up · Very satisfied
|
31 Participants
|
31 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after touch-up · Satisfied
|
15 Participants
|
13 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after touch-up · Somewhat satisfied
|
3 Participants
|
2 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after touch-up · Somewhat dissatisfied
|
3 Participants
|
6 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after touch-up · Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Ease of injection after touch-up · Very dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Mouldability after initial injection · Very satisfied
|
35 Participants
|
34 Participants
|
—
|
|
Injector Satisfaction
Mouldability after initial injection · Satisfied
|
20 Participants
|
19 Participants
|
—
|
|
Injector Satisfaction
Mouldability after initial injection · Somewhat satisfied
|
0 Participants
|
1 Participants
|
—
|
|
Injector Satisfaction
Mouldability after initial injection · Somewhat dissatisfied
|
0 Participants
|
1 Participants
|
—
|
|
Injector Satisfaction
Mouldability after initial injection · Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Mouldability after initial injection · Very dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Mouldability after touch-up · Very satisfied
|
29 Participants
|
29 Participants
|
—
|
|
Injector Satisfaction
Mouldability after touch-up · Satisfied
|
17 Participants
|
22 Participants
|
—
|
|
Injector Satisfaction
Mouldability after touch-up · Somewhat satisfied
|
6 Participants
|
1 Participants
|
—
|
|
Injector Satisfaction
Mouldability after touch-up · Somewhat dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Mouldability after touch-up · Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Mouldability after touch-up · Very dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after initial injection · Very satisfied
|
27 Participants
|
26 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after initial injection · Satisfied
|
23 Participants
|
25 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after initial injection · Somewhat satisfied
|
5 Participants
|
4 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after initial injection · Somewhat dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after initial injection · Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after initial injection · Very dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after touch-up · Very satisfied
|
26 Participants
|
25 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after touch-up · Satisfied
|
23 Participants
|
25 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after touch-up · Somewhat satisfied
|
2 Participants
|
2 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after touch-up · Somewhat dissatisfied
|
1 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after touch-up · Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Ease of product positioning after touch-up · Very dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Immediate result after initial injection · Very satisfied
|
16 Participants
|
8 Participants
|
—
|
|
Injector Satisfaction
Immediate result after initial injection · Satisfied
|
31 Participants
|
32 Participants
|
—
|
|
Injector Satisfaction
Immediate result after initial injection · Somewhat satisfied
|
7 Participants
|
11 Participants
|
—
|
|
Injector Satisfaction
Immediate result after initial injection · Somewhat dissatisfied
|
1 Participants
|
4 Participants
|
—
|
|
Injector Satisfaction
Immediate result after initial injection · Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Immediate result after initial injection · Very dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Immediate result after touch-up · Very satisfied
|
27 Participants
|
25 Participants
|
—
|
|
Injector Satisfaction
Immediate result after touch-up · Satisfied
|
24 Participants
|
25 Participants
|
—
|
|
Injector Satisfaction
Immediate result after touch-up · Somewhat satisfied
|
1 Participants
|
2 Participants
|
—
|
|
Injector Satisfaction
Immediate result after touch-up · Somewhat dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Immediate result after touch-up · Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Immediate result after touch-up · Very dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Result after massage (initial inejction) · Very satisfied
|
15 Participants
|
10 Participants
|
—
|
|
Injector Satisfaction
Result after massage (initial inejction) · Satisfied
|
31 Participants
|
33 Participants
|
—
|
|
Injector Satisfaction
Result after massage (initial inejction) · Somewhat satisfied
|
8 Participants
|
9 Participants
|
—
|
|
Injector Satisfaction
Result after massage (initial inejction) · Somewhat dissatisfied
|
1 Participants
|
3 Participants
|
—
|
|
Injector Satisfaction
Result after massage (initial inejction) · Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Result after massage (initial inejction) · Very dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Result after massage (touch-up) · Very satisfied
|
26 Participants
|
26 Participants
|
—
|
|
Injector Satisfaction
Result after massage (touch-up) · Satisfied
|
26 Participants
|
26 Participants
|
—
|
|
Injector Satisfaction
Result after massage (touch-up) · Somewhat satisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Result after massage (touch-up) · Somewhat dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Result after massage (touch-up) · Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Injector Satisfaction
Result after massage (touch-up) · Very dissatisfied
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24Population: Safety population - any subject having used the investigational device
Proportion of subjects presenting at least one ISR of any severity
Outcome measures
| Measure |
Gana V
n=55 Participants
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
n=55 Participants
Participants received Sculptra in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Gana V Versus Sculptra
Comparison between results obtained for Gana V and results obtained for Sculptra
|
|---|---|---|---|
|
Collection of Injection Site Reactions
M24 · At least one sign
|
2 Participants
|
0 Participants
|
—
|
|
Collection of Injection Site Reactions
D0 after initial injection · No sign
|
3 Participants
|
6 Participants
|
—
|
|
Collection of Injection Site Reactions
D0 after initial injection · At least one sign
|
52 Participants
|
49 Participants
|
—
|
|
Collection of Injection Site Reactions
M11/2 before touch-up · No sign
|
50 Participants
|
54 Participants
|
—
|
|
Collection of Injection Site Reactions
M11/2 before touch-up · At least one sign
|
5 Participants
|
1 Participants
|
—
|
|
Collection of Injection Site Reactions
M11/2 after touch-up · No sign
|
1 Participants
|
5 Participants
|
—
|
|
Collection of Injection Site Reactions
M11/2 after touch-up · At least one sign
|
51 Participants
|
47 Participants
|
—
|
|
Collection of Injection Site Reactions
M3 · No sign
|
44 Participants
|
47 Participants
|
—
|
|
Collection of Injection Site Reactions
M3 · At least one sign
|
5 Participants
|
2 Participants
|
—
|
|
Collection of Injection Site Reactions
M6 · No sign
|
49 Participants
|
51 Participants
|
—
|
|
Collection of Injection Site Reactions
M6 · At least one sign
|
4 Participants
|
2 Participants
|
—
|
|
Collection of Injection Site Reactions
M9 · No sign
|
45 Participants
|
46 Participants
|
—
|
|
Collection of Injection Site Reactions
M9 · At least one sign
|
3 Participants
|
2 Participants
|
—
|
|
Collection of Injection Site Reactions
M12 · No sign
|
43 Participants
|
45 Participants
|
—
|
|
Collection of Injection Site Reactions
M12 · At least one sign
|
4 Participants
|
2 Participants
|
—
|
|
Collection of Injection Site Reactions
M18 · No sign
|
47 Participants
|
48 Participants
|
—
|
|
Collection of Injection Site Reactions
M18 · At least one sign
|
2 Participants
|
1 Participants
|
—
|
|
Collection of Injection Site Reactions
M24 · No sign
|
47 Participants
|
49 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Month 24Population: Safety population - any subject having used the investigational device
Number of Adverse Events (AEs) Number of Adverse Device Effects (ADEs) Proportion of subjects with at least one AE Proportion of subject with at least one ADE
Outcome measures
| Measure |
Gana V
n=110 Nasolabial fold
Participants received Gana V in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Sculptra
n=55 Nasolabial fold
Participants received Sculptra in one nasolabial fold (as per randomization list-split face design).1ml maximum of product could be used at the initial visit (D0) and 1ml maximum could be used 1 month and a half after the initial visit (touch-up not mandatory).
|
Gana V Versus Sculptra
n=55 Nasolabial fold
Comparison between results obtained for Gana V and results obtained for Sculptra
|
|---|---|---|---|
|
Collection of Adverse Events
Proportion of subjects with at least one SAE : Without
|
54 participants
|
54 participants
|
54 participants
|
|
Collection of Adverse Events
Proportion of subjects with at least one AE : With
|
43 participants
|
43 participants
|
43 participants
|
|
Collection of Adverse Events
Proportion of subjects with at least one AE : Without
|
12 participants
|
12 participants
|
12 participants
|
|
Collection of Adverse Events
Proportion of subjects with at least one SAE : With
|
1 participants
|
1 participants
|
1 participants
|
|
Collection of Adverse Events
Proportion of subjects with at least one ADE : With
|
18 participants
|
17 participants
|
14 participants
|
|
Collection of Adverse Events
Proportion of subjects with at least one ADE : Without
|
37 participants
|
38 participants
|
41 participants
|
|
Collection of Adverse Events
proportion of subects with at least one SADE : With
|
0 participants
|
0 participants
|
0 participants
|
|
Collection of Adverse Events
proportion of subects with at least one SADE : Without
|
55 participants
|
55 participants
|
55 participants
|
Adverse Events
Gana V
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Sculptra
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gana V
n=55 participants at risk
All nasolabial fold who received injection with Gana V®
|
Sculptra
n=55 participants at risk
All nasolabial fold who received injection with Sculptra®
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Femoral fracture
|
1.8%
1/55 • Number of events 1 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
1.8%
1/55 • Number of events 1 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
Other adverse events
| Measure |
Gana V
n=55 participants at risk
All nasolabial fold who received injection with Gana V®
|
Sculptra
n=55 participants at risk
All nasolabial fold who received injection with Sculptra®
|
|---|---|---|
|
Eye disorders
Eye disorder
|
3.6%
2/55 • Number of events 2 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
3.6%
2/55 • Number of events 2 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
9.1%
5/55 • Number of events 6 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
9.1%
5/55 • Number of events 6 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
General disorders
General disorders and administration site conditions
|
52.7%
29/55 • Number of events 70 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
54.5%
30/55 • Number of events 64 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
Infections and infestations
Infection
|
27.3%
15/55 • Number of events 19 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
27.3%
15/55 • Number of events 19 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
Musculoskeletal and connective tissue disorders
Muskulokeletal disorders
|
20.0%
11/55 • Number of events 17 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
20.0%
11/55 • Number of events 17 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
Nervous system disorders
Headache / Migraine
|
25.5%
14/55 • Number of events 50 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
25.5%
14/55 • Number of events 50 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia / Tracheitis
|
3.6%
2/55 • Number of events 3 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
3.6%
2/55 • Number of events 3 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
Skin and subcutaneous tissue disorders
Acne, seborrheic dermatitis, burn
|
5.5%
3/55 • Number of events 3 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
5.5%
3/55 • Number of events 3 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place