Wrinkle
Conditions
Brief summary
The purpose of this study is to assess the effectiveness and safety of Gana V, a Poly L-lactic acid filler for the aesthetic treatment of nasolabial folds, in comparison with Sculptra.
Detailed description
A screening visit will allow to inform and preselect the participants. On D0, baseline scoring, fringe projection acquisitions and photographs will be done before injection. Eligible participants will receive a first injection of the two products according to the randomization list. Immediately after injection, injector's treatment satisfaction will be collected. Investigator evaluator will collect Adverse Events (AEs) and Injection Site Reactions (ISRs) immediately after injection. A month and a half after initial injection (M11/2), clinical scoring, fringe projection acquisitions and photographs will be done before touch-up (if applicable). Participant's treatment satisfaction and injector's treatment satisfaction (if applicable) will be collected. A touch-up injection will be made if necessary, according to injector and participant opinion. Investigator evaluator will collect AEs and ISRs before and after touch-up if applicable. Three (M3), six (M6), nine (M9), twelve (M12), eighteen (M18) and twenty-four (M24) months after initial injection, clinical scoring, fringe projection acquisitions and photographs will be done. Participant's treatment satisfaction will be collected. Investigator evaluator will collect AEs and ISRs
Interventions
DEVICEGana V®
Injection in the deep dermis and subcutaneous layer of the nasolabial fold on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up).
DEVICESculptra®
Injection in the deep dermis and subcutaneous layer of the nasolabial fold on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up).
Sponsors
Eurofins Dermscan Pharmascan
GCS Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants and investigators assessors will not know which filler was used on each side of the face (hemi-face design)
Intervention model description
All participants will receive both fillers
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject with moderate to severe nasolabial folds as determined by a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 on both folds at the pre-treatment evaluation. * Subject wiling to abstain from other facial procedures (i.e., dermal fillers, toxin treatments, laser, microdermal abrasion, chemical peels, non-invasive skin-tightening) during the whole study period. * Subject, psychologically able to understand the study related information and to give a written informed consent. * Subject having given freely and expressly his/her informed consent. * Subject willing to have photographs of the face taken. * Subject affiliated to a health social security system. * Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit and during the whole study period.
Exclusion criteria
* Pregnant or nursing woman or planning a pregnancy during the study. * Subject with a scar, moles, pigment disorders or anything on the face which might interfere with the evaluation. * Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. * Subject in a social or sanitary establishment * Subject participation to another research on human beings or who is in an exclusion period of one. * Subject having received 4500 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present study. * Subject suspected to be non-compliant according to the investigator's judgment. * Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results. * Subject with known history of or suffering from autoimmune disease and/or immune deficiency. * Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (e.g. acne, mycosis, papilloma, chronic eczema, atopic dermatitis…). Subject with labial herpes in the last 2 years is not eligible even if asymptomatic at time of screening visit. * Subject with an abscess, unhealed wound, or a cancerous or precancerous lesion on the studied zone. * Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders. * Subject with a tendency to develop keloids or hypertrophic scarring. * Subject having history of allergy or anaphylactic shock including hypersensitivity to Poly-l-lactic acid, to lidocaine or to one of the components of the tested devices or antiseptic solution. * Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to screening visit. * Subject having received injection with a resorbable filling product in the face area within the past 12 months prior to screening visit. * Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …) on the face. * Subject having received at any time a treatment with tensor threads on the face. * Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to screening visit. * Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAID) (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants or other substances known to prolong bleeding time within 1 week prior to injection visits. * Subject undergoing a topical treatment on the test area or a systemic treatment: * Antihistamines during the 2 weeks prior to screening visit. * Immunosuppressors and/or corticoids during the 4 weeks prior to screening visit. * Retinoids during the 6 months prior to screening visit. * Intensive exposure to sunlight or UV-rays within the previous month before and after injection visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment | Baseline and Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WSRS Responders Rate | Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | 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) |
| Global Aesthetic Improvement Scale (GAIS) Responder Rate | Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | 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. |
| Change From Baseline in Nasolabial Folds Average Depth (mm) | Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | 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 |
| Change From Baseline in Nasolabial Folds Volume | Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | The volume of the nasolabial folds wrinkles was calculated using a fringe projection system. A decrease of the volume means a positive outcome. |
| Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | 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. |
| Injector Satisfaction | After initial injection (Day 0) and touch-up if applicable (Month 1^1/2) | Percentage of participants |
| Collection of Injection Site Reactions | Day 0, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | Proportion of subjects presenting at least one ISR of any severity |
| Collection of Adverse Events | Day 0 to Month 24 | 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 |
| Proportion of Satisfied Participants | Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | Percentage of participants with positive answers to an internal questionnaire |
Countries
France
Participant flow
Recruitment details
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.
Pre-assignment details
4 subjects were enrolled but not randomized in the study due to consent withdrawal or because they were lost to follow-up
Participants by arm
| Arm | Count |
|---|---|
| Gana V Versus Sculptra Participants received both Gana V and Sculptra: one in each nasolabial folds | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Gana V Versus Sculptra | — |
|---|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 8.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 55 participants | — |
| Sex: Female, Male Female | 48 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 42 / 55 | 42 / 55 |
| serious Total, serious adverse events | 1 / 55 | 1 / 55 |
Outcome results
Primary
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment
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.
Time frame: Baseline and Month 6
Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gana V | 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 |
| Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment | -0.2 score on a scale |
| Gana V Versus Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment | -0.1 score on a scale |
Comparison: Difference of changes from baseline in WSRS score for Gana V versus Sculptra
Secondary
Change From Baseline in Nasolabial Folds Average Depth (mm)
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
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gana V | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M3 visit | 0.008 mm | Standard Deviation 0.022 |
| Gana V | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M12 visit | 0.008 mm | Standard Deviation 0.027 |
| Gana V | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M9 visit | 0.008 mm | Standard Deviation 0.024 |
| Gana V | 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 |
| Gana V | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M24 visit | -0.002 mm | Standard Deviation 0.033 |
| Gana V | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M18 visit | 0.008 mm | Standard Deviation 0.034 |
| Gana V | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M6 visit | 0.005 mm | Standard Deviation 0.026 |
| Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M9 visit | 0.031 mm | Standard Deviation 0.028 |
| Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M11/2 visit | 0.018 mm | Standard Deviation 0.017 |
| Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M3 visit | 0.029 mm | Standard Deviation 0.025 |
| Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M6 visit | 0.029 mm | Standard Deviation 0.028 |
| Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M12 visit | 0.029 mm | Standard Deviation 0.03 |
| Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M18 visit | 0.029 mm | Standard Deviation 0.027 |
| Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M24 visit | 0.016 mm | Standard Deviation 0.022 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M12 visit | 0.021 mm | Standard Deviation 0.02 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M3 visit | 0.021 mm | Standard Deviation 0.017 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M24 visit | 0.016 mm | Standard Deviation 0.031 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M18 visit | 0.020 mm | Standard Deviation 0.027 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M9 visit | 0.023 mm | Standard Deviation 0.021 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M6 visit | 0.024 mm | Standard Deviation 0.021 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Average Depth (mm) | Change from baseline (D0 visit) to M11/2 visit | 0.014 mm | Standard Deviation 0.016 |
Secondary
Change From Baseline in Nasolabial Folds Volume
The volume of the nasolabial folds wrinkles was calculated using a fringe projection system. A decrease of the volume means a positive outcome.
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gana V | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M6 visit | -0.782 mm3 | Standard Deviation 1.918 |
| Gana V | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M11/2 visit | -0.606 mm3 | Standard Deviation 1.707 |
| Gana V | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M9 visit | -1.041 mm3 | Standard Deviation 1.919 |
| Gana V | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M18 visit | -0.909 mm3 | Standard Deviation 2.383 |
| Gana V | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M3 visit | -0.840 mm3 | Standard Deviation 1.914 |
| Gana V | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M24 visit | 0.161 mm3 | Standard Deviation 2.392 |
| Gana V | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M12 visit | -0.832 mm3 | Standard Deviation 1.985 |
| Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M24 visit | -0.949 mm3 | Standard Deviation 2.031 |
| Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M3 visit | -2.458 mm3 | Standard Deviation 2.271 |
| Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M6 visit | -2.591 mm3 | Standard Deviation 2.038 |
| Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M9 visit | -2.719 mm3 | Standard Deviation 2.059 |
| Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M12 visit | -2.281 mm3 | Standard Deviation 2.232 |
| Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M18 visit | -2.351 mm3 | Standard Deviation 2.305 |
| Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M11/2 visit | -1.444 mm3 | Standard Deviation 1.692 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M18 visit | -1.442 mm3 | Standard Deviation 2.162 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M12 visit | -1.449 mm3 | Standard Deviation 1.707 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M11/2 visit | -0.838 mm3 | Standard Deviation 1.408 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M6 visit | -1.809 mm3 | Standard Deviation 1.709 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M24 visit | -0.939 mm3 | Standard Deviation 2.496 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M9 visit | -1.677 mm3 | Standard Deviation 1.956 |
| Gana V Versus Sculptra | Change From Baseline in Nasolabial Folds Volume | Change from baseline (D0 visit) to M3 visit | -1.619 mm3 | Standard Deviation 1.938 |
Secondary
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
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.
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gana V | 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 |
| Gana V | 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 |
| Gana V | 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 |
| Gana V | 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 |
| Gana V | 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 |
| Gana V | 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 |
| Gana V | 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 |
| Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 visit) to M6 visit | -0.3 score on a scale | Standard Deviation 0.4 |
| 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 |
| Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 visit) to M18 visit | -0.3 score on a scale | Standard Deviation 0.5 |
| Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 visit) to M24 visit | -0.2 score on a scale | Standard Deviation 0.5 |
| Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 visit) to M12 visit | -0.4 score on a scale | Standard Deviation 0.6 |
| Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 0visit) to M9 visit | -0.4 score on a scale | Standard Deviation 0.5 |
| Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 visit) to M3 visit | -0.1 score on a scale | Standard Deviation 0.3 |
| Gana V Versus Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 visit) to M12 visit | -0.3 score on a scale | Standard Deviation 0.5 |
| Gana V Versus Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 visit) to M18 visit | -0.2 score on a scale | Standard Deviation 0.5 |
| Gana V Versus Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 0visit) to M9 visit | -0.3 score on a scale | Standard Deviation 0.4 |
| Gana V Versus Sculptra | 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 0.4 |
| Gana V Versus Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 visit) to M3 visit | -0.1 score on a scale | Standard Deviation 0.3 |
| Gana V Versus 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 | -0.0 score on a scale | Standard Deviation 0.2 |
| Gana V Versus Sculptra | Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) | Change from baseline (D0 visit) to M6 visit | -0.2 score on a scale | Standard Deviation 0.4 |
Secondary
Collection of Adverse Events
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
Time frame: Day 0 to Month 24
Population: Safety population - any subject having used the investigational device
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gana V | Collection of Adverse Events | Proportion of subjects with at least one SAE : With | 1 participants |
| Gana V | Collection of Adverse Events | Proportion of subjects with at least one AE : With | 43 participants |
| Gana V | Collection of Adverse Events | Proportion of subjects with at least one SAE : Without | 54 participants |
| Gana V | Collection of Adverse Events | proportion of subects with at least one SADE : With | 0 participants |
| Gana V | Collection of Adverse Events | Proportion of subjects with at least one AE : Without | 12 participants |
| Gana V | Collection of Adverse Events | Proportion of subjects with at least one ADE : With | 18 participants |
| Gana V | Collection of Adverse Events | proportion of subects with at least one SADE : Without | 55 participants |
| Gana V | Collection of Adverse Events | Proportion of subjects with at least one ADE : Without | 37 participants |
| Sculptra | Collection of Adverse Events | Proportion of subjects with at least one AE : Without | 12 participants |
| Sculptra | Collection of Adverse Events | Proportion of subjects with at least one ADE : Without | 38 participants |
| Sculptra | Collection of Adverse Events | Proportion of subjects with at least one AE : With | 43 participants |
| Sculptra | Collection of Adverse Events | proportion of subects with at least one SADE : With | 0 participants |
| Sculptra | Collection of Adverse Events | proportion of subects with at least one SADE : Without | 55 participants |
| Sculptra | Collection of Adverse Events | Proportion of subjects with at least one SAE : With | 1 participants |
| Sculptra | Collection of Adverse Events | Proportion of subjects with at least one SAE : Without | 54 participants |
| Sculptra | Collection of Adverse Events | Proportion of subjects with at least one ADE : With | 17 participants |
| Gana V Versus Sculptra | Collection of Adverse Events | proportion of subects with at least one SADE : Without | 55 participants |
| Gana V Versus Sculptra | Collection of Adverse Events | Proportion of subjects with at least one AE : With | 43 participants |
| Gana V Versus Sculptra | Collection of Adverse Events | Proportion of subjects with at least one AE : Without | 12 participants |
| Gana V Versus Sculptra | Collection of Adverse Events | Proportion of subjects with at least one SAE : With | 1 participants |
| Gana V Versus Sculptra | Collection of Adverse Events | Proportion of subjects with at least one SAE : Without | 54 participants |
| Gana V Versus Sculptra | Collection of Adverse Events | Proportion of subjects with at least one ADE : With | 14 participants |
| Gana V Versus Sculptra | Collection of Adverse Events | Proportion of subjects with at least one ADE : Without | 41 participants |
| Gana V Versus Sculptra | Collection of Adverse Events | proportion of subects with at least one SADE : With | 0 participants |
Secondary
Collection of Injection Site Reactions
Proportion of subjects presenting at least one ISR of any severity
Time frame: Day 0, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Population: Safety population - any subject having used the investigational device
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gana V | Collection of Injection Site Reactions | M6 | At least one sign | 4 Participants |
| Gana V | Collection of Injection Site Reactions | M9 | No sign | 45 Participants |
| Gana V | Collection of Injection Site Reactions | M12 | At least one sign | 4 Participants |
| Gana V | Collection of Injection Site Reactions | D0 after initial injection | No sign | 3 Participants |
| Gana V | Collection of Injection Site Reactions | D0 after initial injection | At least one sign | 52 Participants |
| Gana V | Collection of Injection Site Reactions | M11/2 before touch-up | No sign | 50 Participants |
| Gana V | Collection of Injection Site Reactions | M11/2 before touch-up | At least one sign | 5 Participants |
| Gana V | Collection of Injection Site Reactions | M11/2 after touch-up | No sign | 1 Participants |
| Gana V | Collection of Injection Site Reactions | M11/2 after touch-up | At least one sign | 51 Participants |
| Gana V | Collection of Injection Site Reactions | M3 | No sign | 44 Participants |
| Gana V | Collection of Injection Site Reactions | M3 | At least one sign | 5 Participants |
| Gana V | Collection of Injection Site Reactions | M6 | No sign | 49 Participants |
| Gana V | Collection of Injection Site Reactions | M9 | At least one sign | 3 Participants |
| Gana V | Collection of Injection Site Reactions | M12 | No sign | 43 Participants |
| Gana V | Collection of Injection Site Reactions | M18 | No sign | 47 Participants |
| Gana V | Collection of Injection Site Reactions | M18 | At least one sign | 2 Participants |
| Gana V | Collection of Injection Site Reactions | M24 | No sign | 47 Participants |
| Gana V | Collection of Injection Site Reactions | M24 | At least one sign | 2 Participants |
| Sculptra | Collection of Injection Site Reactions | M12 | At least one sign | 2 Participants |
| Sculptra | Collection of Injection Site Reactions | M6 | At least one sign | 2 Participants |
| Sculptra | Collection of Injection Site Reactions | M3 | No sign | 47 Participants |
| Sculptra | Collection of Injection Site Reactions | M9 | No sign | 46 Participants |
| Sculptra | Collection of Injection Site Reactions | M12 | No sign | 45 Participants |
| Sculptra | Collection of Injection Site Reactions | M24 | At least one sign | 0 Participants |
| Sculptra | Collection of Injection Site Reactions | M3 | At least one sign | 2 Participants |
| Sculptra | Collection of Injection Site Reactions | D0 after initial injection | No sign | 6 Participants |
| Sculptra | Collection of Injection Site Reactions | M18 | No sign | 48 Participants |
| Sculptra | Collection of Injection Site Reactions | D0 after initial injection | At least one sign | 49 Participants |
| Sculptra | Collection of Injection Site Reactions | M6 | No sign | 51 Participants |
| Sculptra | Collection of Injection Site Reactions | M11/2 before touch-up | No sign | 54 Participants |
| Sculptra | Collection of Injection Site Reactions | M24 | No sign | 49 Participants |
| Sculptra | Collection of Injection Site Reactions | M11/2 before touch-up | At least one sign | 1 Participants |
| Sculptra | Collection of Injection Site Reactions | M9 | At least one sign | 2 Participants |
| Sculptra | Collection of Injection Site Reactions | M11/2 after touch-up | No sign | 5 Participants |
| Sculptra | Collection of Injection Site Reactions | M18 | At least one sign | 1 Participants |
| Sculptra | Collection of Injection Site Reactions | M11/2 after touch-up | At least one sign | 47 Participants |
Secondary
Global Aesthetic Improvement Scale (GAIS) Responder Rate
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.
Time frame: Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M12 | Responder | 29 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M11/2 | Responder | 20 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M11/2 | Not responder | 35 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M3 | Responder | 21 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M3 | Not responder | 28 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M6 | Responder | 38 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M6 | Not responder | 15 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M9 | Responder | 32 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M9 | Not responder | 16 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M12 | Responder | 30 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M12 | Not responder | 16 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M18 | Responder | 26 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M18 | Not responder | 23 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M24 | Responder | 16 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M24 | Not responder | 33 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M11/2 | Responder | 27 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M11/2 | Not responder | 28 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M3 | Responder | 34 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M3 | Not responder | 19 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M6 | Responder | 35 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M6 | Not responder | 18 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M9 | Responder | 32 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M9 | Not responder | 15 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M12 | Not responder | 18 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M18 | Responder | 29 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M18 | Not responder | 20 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M24 | Responder | 21 Participants |
| Gana V | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M24 | Not responder | 28 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M24 | Responder | 17 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M12 | Responder | 28 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M18 | Not responder | 18 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M6 | Not responder | 19 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M11/2 | Responder | 18 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M24 | Not responder | 32 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M11/2 | Not responder | 37 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M24 | Not responder | 25 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M3 | Responder | 17 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M11/2 | Responder | 27 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M3 | Not responder | 32 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M9 | Responder | 28 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M6 | Responder | 29 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M11/2 | Not responder | 28 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M6 | Not responder | 24 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M18 | Responder | 31 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M9 | Responder | 31 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M3 | Responder | 32 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M9 | Not responder | 17 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M9 | Not responder | 20 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M12 | Responder | 28 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M3 | Not responder | 21 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M12 | Not responder | 18 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M24 | Responder | 24 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M18 | Responder | 27 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M6 | Responder | 34 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M18 | Not responder | 22 Participants |
| Sculptra | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subjects at M12 | Not responder | 19 Participants |
Secondary
Injector Satisfaction
Percentage of participants
Time frame: 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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gana V | Injector Satisfaction | Ease of product positioning after initial injection | Very satisfied | 27 Participants |
| Gana V | Injector Satisfaction | Ease of injection after initial injection | Somewhat dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after initial injection | Satisfied | 23 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after touch-up | Somewhat satisfied | 2 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after initial injection | Somewhat satisfied | 5 Participants |
| Gana V | Injector Satisfaction | Ease of injection after initial injection | Dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after initial injection | Somewhat dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Immediate result after touch-up | Somewhat satisfied | 1 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after initial injection | Dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Ease of injection after initial injection | Very dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after initial injection | Very dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Mouldability after initial injection | Satisfied | 20 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after touch-up | Very satisfied | 26 Participants |
| Gana V | Injector Satisfaction | Ease of injection after touch-up | Very satisfied | 31 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after touch-up | Somewhat dissatisfied | 1 Participants |
| Gana V | Injector Satisfaction | Immediate result after touch-up | Somewhat dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after touch-up | Dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Ease of injection after touch-up | Satisfied | 15 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after touch-up | Very dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Mouldability after touch-up | Dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Immediate result after initial injection | Very satisfied | 16 Participants |
| Gana V | Injector Satisfaction | Ease of injection after touch-up | Somewhat satisfied | 3 Participants |
| Gana V | Injector Satisfaction | Immediate result after initial injection | Satisfied | 31 Participants |
| Gana V | Injector Satisfaction | Mouldability after initial injection | Very dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Immediate result after initial injection | Somewhat satisfied | 7 Participants |
| Gana V | Injector Satisfaction | Ease of injection after touch-up | Somewhat dissatisfied | 3 Participants |
| Gana V | Injector Satisfaction | Immediate result after initial injection | Somewhat dissatisfied | 1 Participants |
| Gana V | Injector Satisfaction | Result after massage (initial inejction) | Very satisfied | 15 Participants |
| Gana V | Injector Satisfaction | Immediate result after initial injection | Dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Ease of injection after touch-up | Dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Immediate result after initial injection | Very dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Mouldability after touch-up | Very dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Immediate result after touch-up | Very satisfied | 27 Participants |
| Gana V | Injector Satisfaction | Ease of injection after touch-up | Very dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Immediate result after touch-up | Satisfied | 24 Participants |
| Gana V | Injector Satisfaction | Result after massage (initial inejction) | Satisfied | 31 Participants |
| Gana V | Injector Satisfaction | Immediate result after touch-up | Dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Mouldability after initial injection | Somewhat satisfied | 0 Participants |
| Gana V | Injector Satisfaction | Immediate result after touch-up | Very dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Ease of injection after initial injection | Very satisfied | 32 Participants |
| Gana V | Injector Satisfaction | Result after massage (initial inejction) | Somewhat satisfied | 8 Participants |
| Gana V | Injector Satisfaction | Mouldability after initial injection | Somewhat dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Result after massage (initial inejction) | Somewhat dissatisfied | 1 Participants |
| Gana V | Injector Satisfaction | Mouldability after initial injection | Dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Result after massage (initial inejction) | Dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Mouldability after touch-up | Very satisfied | 29 Participants |
| Gana V | Injector Satisfaction | Result after massage (initial inejction) | Very dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Ease of injection after initial injection | Satisfied | 18 Participants |
| Gana V | Injector Satisfaction | Result after massage (touch-up) | Very satisfied | 26 Participants |
| Gana V | Injector Satisfaction | Mouldability after touch-up | Satisfied | 17 Participants |
| Gana V | Injector Satisfaction | Result after massage (touch-up) | Satisfied | 26 Participants |
| Gana V | Injector Satisfaction | Ease of product positioning after touch-up | Satisfied | 23 Participants |
| Gana V | Injector Satisfaction | Result after massage (touch-up) | Somewhat satisfied | 0 Participants |
| Gana V | Injector Satisfaction | Mouldability after touch-up | Somewhat satisfied | 6 Participants |
| Gana V | Injector Satisfaction | Result after massage (touch-up) | Somewhat dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Ease of injection after initial injection | Somewhat satisfied | 5 Participants |
| Gana V | Injector Satisfaction | Result after massage (touch-up) | Dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Mouldability after touch-up | Somewhat dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Result after massage (touch-up) | Very dissatisfied | 0 Participants |
| Gana V | Injector Satisfaction | Mouldability after initial injection | Very satisfied | 35 Participants |
| Sculptra | Injector Satisfaction | Result after massage (touch-up) | Very dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Mouldability after initial injection | Very satisfied | 34 Participants |
| Sculptra | Injector Satisfaction | Mouldability after initial injection | Satisfied | 19 Participants |
| Sculptra | Injector Satisfaction | Mouldability after initial injection | Dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Mouldability after initial injection | Very dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Mouldability after touch-up | Somewhat dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Mouldability after touch-up | Dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after touch-up | Very satisfied | 25 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after touch-up | Satisfied | 25 Participants |
| Sculptra | Injector Satisfaction | Immediate result after touch-up | Somewhat satisfied | 2 Participants |
| Sculptra | Injector Satisfaction | Immediate result after touch-up | Somewhat dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Immediate result after touch-up | Very dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Result after massage (initial inejction) | Very satisfied | 10 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after initial injection | Very satisfied | 29 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after initial injection | Satisfied | 21 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after initial injection | Somewhat satisfied | 5 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after initial injection | Somewhat dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after initial injection | Dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after initial injection | Very dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after touch-up | Very satisfied | 31 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after touch-up | Satisfied | 13 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after touch-up | Somewhat satisfied | 2 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after touch-up | Somewhat dissatisfied | 6 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after touch-up | Dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of injection after touch-up | Very dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Mouldability after initial injection | Somewhat satisfied | 1 Participants |
| Sculptra | Injector Satisfaction | Mouldability after initial injection | Somewhat dissatisfied | 1 Participants |
| Sculptra | Injector Satisfaction | Mouldability after touch-up | Very satisfied | 29 Participants |
| Sculptra | Injector Satisfaction | Mouldability after touch-up | Satisfied | 22 Participants |
| Sculptra | Injector Satisfaction | Mouldability after touch-up | Somewhat satisfied | 1 Participants |
| Sculptra | Injector Satisfaction | Mouldability after touch-up | Very dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after initial injection | Very satisfied | 26 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after initial injection | Satisfied | 25 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after initial injection | Somewhat satisfied | 4 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after initial injection | Somewhat dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after initial injection | Dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after initial injection | Very dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after touch-up | Somewhat satisfied | 2 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after touch-up | Somewhat dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after touch-up | Dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Ease of product positioning after touch-up | Very dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Immediate result after initial injection | Very satisfied | 8 Participants |
| Sculptra | Injector Satisfaction | Immediate result after initial injection | Satisfied | 32 Participants |
| Sculptra | Injector Satisfaction | Immediate result after initial injection | Somewhat satisfied | 11 Participants |
| Sculptra | Injector Satisfaction | Immediate result after initial injection | Somewhat dissatisfied | 4 Participants |
| Sculptra | Injector Satisfaction | Immediate result after initial injection | Dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Immediate result after initial injection | Very dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Immediate result after touch-up | Very satisfied | 25 Participants |
| Sculptra | Injector Satisfaction | Immediate result after touch-up | Satisfied | 25 Participants |
| Sculptra | Injector Satisfaction | Immediate result after touch-up | Dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Result after massage (initial inejction) | Satisfied | 33 Participants |
| Sculptra | Injector Satisfaction | Result after massage (initial inejction) | Somewhat satisfied | 9 Participants |
| Sculptra | Injector Satisfaction | Result after massage (initial inejction) | Somewhat dissatisfied | 3 Participants |
| Sculptra | Injector Satisfaction | Result after massage (initial inejction) | Dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Result after massage (initial inejction) | Very dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Result after massage (touch-up) | Very satisfied | 26 Participants |
| Sculptra | Injector Satisfaction | Result after massage (touch-up) | Satisfied | 26 Participants |
| Sculptra | Injector Satisfaction | Result after massage (touch-up) | Somewhat satisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Result after massage (touch-up) | Somewhat dissatisfied | 0 Participants |
| Sculptra | Injector Satisfaction | Result after massage (touch-up) | Dissatisfied | 0 Participants |
Secondary
Proportion of Satisfied Participants
Percentage of participants with positive answers to an internal questionnaire
Time frame: Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M9 | Not satisfied | 20 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M11/2 | Not satisfied | 27 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M3 | Satisfied | 34 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M3 | Not satisfied | 19 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M6 | Satisfied | 38 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M3 | Satisfied | 32 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M3 | Not satisfied | 21 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M6 | Satisfied | 35 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M6 | Not satisfied | 15 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M9 | Satisfied | 32 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M9 | Not satisfied | 16 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M12 | Satisfied | 34 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M12 | Not satisfied | 13 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M18 | Satisfied | 32 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M18 | Not satisfied | 17 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M24 | Satisfied | 25 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M24 | Not satisfied | 24 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M11/2 | Satisfied | 29 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M11/2 | Not satisfied | 26 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M3 | Satisfied | 31 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M3 | Not satisfied | 21 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M6 | Satisfied | 37 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M6 | Not satisfied | 16 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M9 | Satisfied | 31 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M9 | Not satisfied | 17 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M12 | Satisfied | 36 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M12 | Not satisfied | 11 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M18 | Satisfied | 32 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M18 | Not satisfied | 17 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M24 | Satisfied | 28 Participants |
| Gana V | Proportion of Satisfied Participants | The result is aesthetically satisfying at M24 | Not satisfied | 21 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M11/2 | Satisfied | 37 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M11/2 | Not satisfied | 18 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M3 | Satisfied | 40 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M3 | Not satisfied | 13 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M6 | Satisfied | 41 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M6 | Not satisfied | 12 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M9 | Satisfied | 37 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M9 | Not satisfied | 11 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M12 | Satisfied | 37 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M12 | Not satisfied | 10 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M18 | Satisfied | 35 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M18 | Not satisfied | 14 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M24 | Satisfied | 32 Participants |
| Gana V | Proportion of Satisfied Participants | The result is natural at M24 | Not satisfied | 16 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M11/2 | Satisfied | 24 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M11/2 | Not satisfied | 31 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M3 | Satisfied | 30 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M3 | Not satisfied | 22 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M6 | Satisfied | 31 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M6 | Not satisfied | 22 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M9 | Satisfied | 28 Participants |
| Gana V | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M11/2 | Satisfied | 28 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M12 | Satisfied | 30 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M12 | Not satisfied | 17 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M18 | Satisfied | 27 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M18 | Not satisfied | 22 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M24 | Satisfied | 22 Participants |
| Gana V | Proportion of Satisfied Participants | The facial volumes are restored at M24 | Not satisfied | 27 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M11/2 | Satisfied | 26 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M11/2 | Not satisfied | 29 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M6 | Not satisfied | 18 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M9 | Satisfied | 31 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M9 | Not satisfied | 16 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M12 | Satisfied | 32 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M12 | Not satisfied | 15 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M18 | Satisfied | 28 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M18 | Not satisfied | 20 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M24 | Satisfied | 25 Participants |
| Gana V | Proportion of Satisfied Participants | My features seem rested at M24 | Not satisfied | 24 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M3 | Not satisfied | 16 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M11/2 | Satisfied | 29 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M12 | Not satisfied | 17 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M11/2 | Not satisfied | 26 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M6 | Satisfied | 40 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M3 | Satisfied | 33 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M9 | Not satisfied | 21 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M3 | Not satisfied | 20 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M6 | Not satisfied | 13 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M11/2 | Not satisfied | 28 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M6 | Not satisfied | 18 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M3 | Satisfied | 32 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M9 | Satisfied | 34 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M3 | Not satisfied | 21 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M12 | Satisfied | 28 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M6 | Satisfied | 35 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M6 | Satisfied | 37 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M9 | Not satisfied | 14 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M6 | Not satisfied | 16 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M24 | Not satisfied | 24 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M9 | Satisfied | 29 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M12 | Satisfied | 36 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M9 | Not satisfied | 19 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M12 | Not satisfied | 19 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M12 | Satisfied | 33 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M12 | Not satisfied | 11 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M12 | Not satisfied | 14 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M9 | Satisfied | 29 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M18 | Satisfied | 29 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M18 | Satisfied | 35 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M18 | Not satisfied | 20 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M18 | Satisfied | 28 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M24 | Satisfied | 24 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M18 | Not satisfied | 14 Participants |
| Sculptra | Proportion of Satisfied Participants | Are you satisfied with how your nasolabial fold looks? at M24 | Not satisfied | 25 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M18 | Satisfied | 29 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M11/2 | Satisfied | 28 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M24 | Satisfied | 30 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M11/2 | Not satisfied | 27 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M18 | Not satisfied | 21 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M3 | Satisfied | 30 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M24 | Not satisfied | 19 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M3 | Not satisfied | 21 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M9 | Not satisfied | 19 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M6 | Satisfied | 36 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M11/2 | Satisfied | 25 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M6 | Not satisfied | 17 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M24 | Satisfied | 21 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M9 | Satisfied | 29 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M11/2 | Not satisfied | 30 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M9 | Not satisfied | 19 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M24 | Satisfied | 25 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M12 | Satisfied | 34 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M3 | Satisfied | 30 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M12 | Not satisfied | 13 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M24 | Not satisfied | 28 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M18 | Satisfied | 30 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M3 | Not satisfied | 22 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M18 | Not satisfied | 19 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M12 | Satisfied | 30 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M24 | Satisfied | 27 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M6 | Satisfied | 34 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is aesthetically satisfying at M24 | Not satisfied | 22 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M11/2 | Satisfied | 27 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M11/2 | Satisfied | 37 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M6 | Not satisfied | 19 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M11/2 | Not satisfied | 18 Participants |
| Sculptra | Proportion of Satisfied Participants | My features seem rested at M18 | Not satisfied | 20 Participants |
| Sculptra | Proportion of Satisfied Participants | The result is natural at M3 | Satisfied | 37 Participants |
| Sculptra | Proportion of Satisfied Participants | The facial volumes are restored at M9 | Satisfied | 27 Participants |
Secondary
WSRS Responders Rate
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)
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Population: Intent To Treat population - any subject included and randomized in the study with at least a post-basal value.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M11/2 visit | Responder | 5 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M11/2 visit | Not responder | 50 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M3 visit | Responder | 6 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M3 visit | Not responder | 43 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M6 visit | Responder | 14 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M6 visit | Not responder | 39 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M9 visit | Responder | 20 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M9 visit | Not responder | 28 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M12 visit | Responder | 16 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M12 visit | Not responder | 31 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M18 visit | Responder | 12 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M18 visit | Not responder | 37 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M24 visit | Responder | 10 Participants |
| Gana V | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M24 visit | Not responder | 39 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M18 visit | Responder | 9 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M11/2 visit | Responder | 2 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M9 visit | Not responder | 35 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M11/2 visit | Not responder | 53 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M24 visit | Responder | 6 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M3 visit | Responder | 6 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M12 visit | Responder | 13 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M3 visit | Not responder | 43 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M18 visit | Not responder | 40 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M6 visit | Responder | 11 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M12 visit | Not responder | 34 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M6 visit | Not responder | 42 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M24 visit | Not responder | 43 Participants |
| Sculptra | WSRS Responders Rate | Responder rate from baseline (D0 visit) to M9 visit | Responder | 13 Participants |