Trial Outcomes & Findings for Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite (NCT NCT05064761)
NCT ID: NCT05064761
Last Updated: 2024-09-26
Results Overview
Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to current visit. On a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 9 were reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
At Month 9
Results posted on
2024-09-26
Participant Flow
This study was conducted at Canada from 19 November 2021 to 27 February 2023.
A total of 29 participants were enrolled in the study. All enrolled participants were treated and completed the study.
Participant milestones
| Measure |
Treatment Group (Sculptra)
Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite
Baseline characteristics by cohort
| Measure |
Treatment Group (Sculptra)
n=29 Participants
Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.
|
|---|---|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 9.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 9Population: Full Analysis Set (FAS) Included all participants who were injected in both thighs.
Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to current visit. On a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 9 were reported.
Outcome measures
| Measure |
Treatment Group (Sculptra)
n=58 Thighs
Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.
|
|---|---|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9
Right thigh · No change
|
1 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9
Left thigh · Very much improved
|
23 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9
Left thigh · Much improved
|
4 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9
Left thigh · Improved
|
1 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9
Left thigh · No change
|
1 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9
Right thigh · Very much improved
|
24 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9
Right thigh · Much improved
|
3 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9
Right thigh · Improved
|
1 Thighs
|
SECONDARY outcome
Timeframe: At month 1, 2, 6 and 12Population: Full Analysis Set (FAS) Included all participants who were injected in both thighs.
Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 1,2,6 and 12 were reported.
Outcome measures
| Measure |
Treatment Group (Sculptra)
n=58 Thighs
Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.
|
|---|---|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 1, Left thigh · Much improved
|
8 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 12, Left thigh · Improved
|
1 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 12, Left thigh · No change
|
0 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 12, Right thigh · Very much improved
|
19 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 12, Right thigh · Much improved
|
8 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 12, Right thigh · Improved
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 12, Right thigh · No change
|
0 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 1, Left thigh · Very much improved
|
0 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 1, Left thigh · Improved
|
16 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 1, Left thigh · No change
|
5 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 1, Right thigh · Very much improved
|
1 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 1, Right thigh · Much improved
|
6 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 1, Right thigh · Improved
|
17 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 1, Right thigh · No change
|
5 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 2, Left thigh · Very much improved
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 2, Left thigh · Much improved
|
8 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 2, Left thigh · Improved
|
19 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 2, Left thigh · No change
|
0 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 2, Right thigh · Very much improved
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 2, Right thigh · Much improved
|
8 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 2, Right thigh · Improved
|
19 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 2, Right thigh · No change
|
0 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 6, Left thigh · Very much improved
|
16 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 6, Left thigh · Much improved
|
7 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 6, Left thigh · Improved
|
6 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 6, Left thigh · No change
|
0 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 6, Right thigh · Very much improved
|
16 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 6, Right thigh · Much improved
|
6 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 6, Right thigh · Improved
|
7 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 6, Right thigh · No change
|
0 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 12, Left thigh · Very much improved
|
18 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Month 12, Left thigh · Much improved
|
10 Thighs
|
SECONDARY outcome
Timeframe: At Months 1, 2, 6, 9 and 12Population: Full Analysis Set (FAS) Included all participants who were injected in both thighs. Here, "Number analyzed" signifies those units (thighs) which were evaluable at the specified timeframe.
Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by themselves (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on participant photography assessment using GAIS at Month 1,2,6 and 12 were reported.
Outcome measures
| Measure |
Treatment Group (Sculptra)
n=58 Thighs
Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.
|
|---|---|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 1, Left thigh · Very much improved
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 1, Left thigh · Much improved
|
3 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 1, Left thigh · Improved
|
19 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 1, Left thigh · No change
|
5 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 1, Right thigh · Very much improved
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 1, Right thigh · Much improved
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 1, Right thigh · Improved
|
20 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 1, Right thigh · No change
|
5 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 2, Left thigh · Very much improved
|
5 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 2, Left thigh · Much improved
|
8 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 2, Left thigh · Improved
|
14 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 2, Left thigh · No change
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 2, Right thigh · Very much improved
|
4 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 2, Right thigh · Much improved
|
9 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 2, Right thigh · Improved
|
14 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 2, Right thigh · No change
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 6, Left thigh · Very much improved
|
6 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 6, Left thigh · Much improved
|
9 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 6, Left thigh · Improved
|
11 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 6, Left thigh · No change
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 6, Right thigh · Very much improved
|
6 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 6, Right thigh · Much improved
|
8 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 6, Right thigh · Improved
|
13 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 6, Right thigh · No change
|
1 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 9, Left thigh · Very much improved
|
11 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 9, Left thigh · Much improved
|
5 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 9, Left thigh · Improved
|
11 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 9, Left thigh · No change
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 9, Right thigh · Very much improved
|
11 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 9, Right thigh · Much improved
|
5 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 9, Right thigh · Improved
|
12 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 9, Right thigh · No change
|
1 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 12, Left thigh · Very much improved
|
12 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 12, Left thigh · Much improved
|
5 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 12, Left thigh · Improved
|
10 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 12, Left thigh · No change
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 12, Right thigh · Very much improved
|
11 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 12, Right thigh · Much improved
|
6 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 12, Right thigh · No change
|
2 Thighs
|
|
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Month 12, Right thigh · Improved
|
10 Thighs
|
Adverse Events
Treatment Group (Sculptra)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group (Sculptra)
n=29 participants at risk
Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.
|
|---|---|
|
Infections and infestations
Bronchitis
|
3.4%
1/29 • Up to 12 months
|
|
Infections and infestations
COVID-19
|
6.9%
2/29 • Up to 12 months
|
|
Infections and infestations
Nasopharyngitis
|
10.3%
3/29 • Up to 12 months
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • Up to 12 months
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.4%
1/29 • Up to 12 months
|
|
Renal and urinary disorders
Urethral prolapse
|
3.4%
1/29 • Up to 12 months
|
Additional Information
Clinical Project Manager
Galderma Research and Development, LLC (GLLC)
Phone: +1 817-961-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place