Cellulite
Conditions
Brief summary
This pilot study has been designed to evaluate the safety and effectiveness of PLLA as a single regimen for the improvement in appearance of cellulite after changes in reconstitution procedure.
Detailed description
Cellulite is a topographic and localized skin condition that is commonly found on the posterolateral thighs, buttocks, and abdomen. It is often identified by a dimpled or orange-peel appearance of the skin's surface. The presence of visible cellulite is associated with histologic changes in the dermis, adipose tissue, and septae. Based on the theory that a stronger skin structure, with a decrease in skin laxity and increase in dermal thickness, could reduce the appearance of cellulite, the Sponsor intends to investigate the safety and effectiveness of PLLA for the improvement in appearance of cellulite in the posterior thighs.
Interventions
DEVICESculptra new dilution
Treatment to improve appearance of cellulite.
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects with intent to undergo treatment to improve appearance of cellulite in the posterior thighs.
Exclusion criteria
* Known/previous allergy or hypersensitivity to any of the Sculptra constituents. * Known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve blocking agents. * Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions. * Previous treatment/procedure in or near the treatment area: 1. Previous permanent implant, filler, lifting threads, or autologous fat in the treatment area, regardless of time. 2. Previous semi-permanent implants exemplified by Calcium Hydroxylapatite (CaHA), poly l-lactic acid (PLLA) in treatment area, regardless of time. 3. Previous Hyaluronic acid (HA) filler or collagen filler in the treatment area within 12 months. 4. Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and endermology) in the treatment area within 6 months. 5. Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. chemical peel) in the treatment area within 6 months. 6. Previous treatment with cryotherapy, lipolytic treatments or liporeduction massage in the treatment area within 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9 | At Month 9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At month 1, 2, 6 and 12 | 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. |
| 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 | At Months 1, 2, 6, 9 and 12 | 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. |
Countries
Canada
Participant flow
Recruitment details
This study was conducted at Canada from 19 November 2021 to 27 February 2023.
Pre-assignment details
A total of 29 participants were enrolled in the study. All enrolled participants were treated and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Treatment Group (Sculptra) |
|---|---|
| Age, Continuous | 41.2 years STANDARD_DEVIATION 9.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 10 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9
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.
Time frame: At Month 9
Population: Full Analysis Set (FAS) Included all participants who were injected in both thighs.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
Secondary
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
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.
Time frame: At Months 1, 2, 6, 9 and 12
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
Secondary
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
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.
Time frame: At month 1, 2, 6 and 12
Population: Full Analysis Set (FAS) Included all participants who were injected in both thighs.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |
| Treatment Group (Sculptra) | 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 |