Cheek Wrinkles
Conditions
Brief summary
The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.
Interventions
DEVICESculptra Aesthetic new dilution
Treatment of cheek wrinkles
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Intent to undergo correction of cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.
Exclusion criteria
* Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents. * Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit: 1. Collagen, Hyaluronic Acid - 12 months 2. Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12 | At Month 12 | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12 | At Months 7, 9, and 12 | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment. |
| Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment | At Month 12 | Improvement rate based on the Independent Photographic Reviewer's assessment using random pairings of baseline and Month 12 photographs was done. An improved subject is defined as a subject for whom the Independent Photographic Reviewer identified the month 12 photograph in the pair as post-treatment. |
| Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | At Months 7, 9, and 12 | GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least Improved when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: How would you describe the aesthetic improvement today compared to the photograph taken before treatment? by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. |
| Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | At Months 7, 9, and 12 | GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least Improved when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: How would you describe the aesthetic improvement today compared to the photograph taken before treatment? by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. |
| Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9 | At Months 7 and 9 | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment. |
| Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree. |
| Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree. |
| Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 12 | A subject satisfaction question with responses Yes or No. |
| Subject Satisfaction: Would You do the Treatment Again? | At Month 12 | A subject satisfaction question with responses Yes or No. |
| Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | Treatment group: Baseline, Months 1, 2, 3, 7, 9 and 12; Control group: Baseline, Months 7, 9 and 12 | The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration up to end of the study (up to Month 12) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important medical event. TEAEs included both serious and non-serious TEAEs. |
| Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Months 7, 9, and 12 | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 13 sites at the United States from 12 November 2019 to12 August 2021.
Pre-assignment details
A total of 149 participants were enrolled and randomized, of which 97 received treatment and 52 received no treatment in this study.
Participants by arm
| Arm | Count |
|---|---|
| Control Group: No-treatment Participants received no treatment during the study. | 52 |
| Treatment Group: Sculptra Aesthetic Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions). | 97 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Medical reason | 0 | 1 |
| Overall Study | Screen failure due to previous use of Radiesse | 1 | 0 |
| Overall Study | Withdrawal of informed consent (due to coronavirus disease-19 concerns) | 1 | 3 |
| Overall Study | Withdrawal of informed consent (not due to coronavirus disease-19 concerns) | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Treatment Group: Sculptra Aesthetic | Control Group: No-treatment |
|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 8.55 | 60.9 years STANDARD_DEVIATION 8.5 | 60.4 years STANDARD_DEVIATION 8.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 137 Participants | 90 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 7 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type score (FST) FST I | 6 Participants | 4 Participants | 2 Participants |
| Fitzpatrick Skin Type score (FST) FST II | 43 Participants | 25 Participants | 18 Participants |
| Fitzpatrick Skin Type score (FST) FST III | 68 Participants | 47 Participants | 21 Participants |
| Fitzpatrick Skin Type score (FST) FST IV | 18 Participants | 12 Participants | 6 Participants |
| Fitzpatrick Skin Type score (FST) FST V | 9 Participants | 5 Participants | 4 Participants |
| Fitzpatrick Skin Type score (FST) FST VI | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 135 Participants | 88 Participants | 47 Participants |
| Sex: Female, Male Female | 144 Participants | 94 Participants | 50 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 97 |
| other Total, other adverse events | 0 / 52 | 11 / 97 |
| serious Total, serious adverse events | 0 / 52 | 3 / 97 |
Outcome results
Primary
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
Time frame: At Month 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group: No-treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12 | 26.1 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12 | 71.6 percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores
The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement.
Time frame: Treatment group: Baseline, Months 1, 2, 3, 7, 9 and 12; Control group: Baseline, Months 7, 9 and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: No-treatment | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 7 | -4.1 score on a scale | Standard Deviation 20.34 |
| Control Group: No-treatment | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 12 | -3.6 score on a scale | Standard Deviation 21.76 |
| Control Group: No-treatment | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 9 | -3.6 score on a scale | Standard Deviation 21.36 |
| Treatment Group: Sculptra Aesthetic | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 3 | 38.6 score on a scale | Standard Deviation 26.51 |
| Treatment Group: Sculptra Aesthetic | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 9 | 37.9 score on a scale | Standard Deviation 26.63 |
| Treatment Group: Sculptra Aesthetic | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 7 | 38.6 score on a scale | Standard Deviation 26.3 |
| Treatment Group: Sculptra Aesthetic | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 12 | 40.0 score on a scale | Standard Deviation 29.07 |
| Treatment Group: Sculptra Aesthetic | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 1 | 21.3 score on a scale | Standard Deviation 24.25 |
| Treatment Group: Sculptra Aesthetic | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 2 | 31.6 score on a scale | Standard Deviation 28.45 |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important medical event. TEAEs included both serious and non-serious TEAEs.
Time frame: From start of study drug administration up to end of the study (up to Month 12)
Population: Safety population (SP) included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: No-treatment | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Non-serious AE | 3 Participants |
| Control Group: No-treatment | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Serious AE | 0 Participants |
| Treatment Group: Sculptra Aesthetic | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Non-serious AE | 43 Participants |
| Treatment Group: Sculptra Aesthetic | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Serious AE | 3 Participants |
Secondary
Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment
GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least Improved when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: How would you describe the aesthetic improvement today compared to the photograph taken before treatment? by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group: No-treatment | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | Month 7 | 6.8 percentage of participants |
| Control Group: No-treatment | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | Month 9 | 4.4 percentage of participants |
| Control Group: No-treatment | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | Month 12 | 4.3 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | Month 9 | 92.9 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | Month 7 | 96.1 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | Month 12 | 94.3 percentage of participants |
Secondary
Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least Improved when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: How would you describe the aesthetic improvement today compared to the photograph taken before treatment? by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group: No-treatment | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | Month 7 | 7.0 percentage of participants |
| Control Group: No-treatment | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | Month 9 | 6.8 percentage of participants |
| Control Group: No-treatment | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | Month 12 | 6.5 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | Month 7 | 93.5 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | Month 9 | 89.4 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | Month 12 | 92.0 percentage of participants |
Secondary
Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment
Improvement rate based on the Independent Photographic Reviewer's assessment using random pairings of baseline and Month 12 photographs was done. An improved subject is defined as a subject for whom the Independent Photographic Reviewer identified the month 12 photograph in the pair as post-treatment.
Time frame: At Month 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group: No-treatment | Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment | Left Cheek | 29.5 percentage of participants |
| Control Group: No-treatment | Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment | Right Cheek | 34.1 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment | Left Cheek | 53.6 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment | Right Cheek | 57.1 percentage of participants |
Secondary
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
Time frame: At Months 7 and 9
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group: No-treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9 | Month 9 | 31.1 percentage of participants |
| Control Group: No-treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9 | Month 7 | 38.6 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9 | Month 9 | 70.6 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9 | Month 7 | 66.2 percentage of participants |
p-value: =0.0043Fisher Exact
p-value: <0.0001Fisher Exact
Secondary
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group: No-treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12 | Month 7 | 27.3 percentage of participants |
| Control Group: No-treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12 | Month 9 | 22.2 percentage of participants |
| Control Group: No-treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12 | Month 12 | 28.3 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12 | Month 12 | 70.5 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12 | Month 7 | 67.5 percentage of participants |
| Treatment Group: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12 | Month 9 | 64.7 percentage of participants |
Secondary
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 7 | Excellent | 17 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 7 | Very Good | 23 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 7 | Good | 13 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 7 | Satisfactory | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 7 | Not Satisfied | 5 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 9 | Excellent | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 9 | Very Good | 28 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 9 | Good | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 9 | Satisfactory | 13 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 9 | Not Satisfied | 7 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 12 | Excellent | 20 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 12 | Very Good | 21 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 12 | Good | 27 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 12 | Satisfactory | 13 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 12 | Not Satisfied | 7 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 7 | Good | 16 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 7 | Excellent | 14 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 7 | Very good | 24 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 7 | Satisfactory | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 7 | Not Satisfied | 5 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 9 | Excellent | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 9 | Very good | 25 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 9 | Good | 25 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 9 | Satisfactory | 9 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 9 | Not Satisfied | 8 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 12 | Excellent | 20 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 12 | Very good | 21 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 12 | Good | 30 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 12 | Satisfactory | 10 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 12 | Not Satisfied | 7 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 7 | Excellent | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 7 | Very good | 24 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 7 | Good | 17 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 7 | Satisfactory | 13 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 7 | Not Satisfied | 5 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 9 | Excellent | 25 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 9 | Very good | 26 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 9 | Good | 16 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 9 | Satisfactory | 11 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 9 | Not Satisfied | 7 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 12 | Excellent | 21 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 12 | Very good | 25 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 12 | Good | 26 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 12 | Satisfactory | 11 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 12 | Not Satisfied | 5 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 12 | Satisfactory | 10 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 7 | Excellent | 21 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 7 | Very good | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 7 | Good | 13 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 7 | Satisfactory | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 7 | Not Satisfied | 5 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 9 | Excellent | 23 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 9 | Very good | 26 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 9 | Good | 13 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 9 | Satisfactory | 17 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 9 | Not Satisfied | 6 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 12 | Excellent | 22 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 12 | Very good | 23 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 12 | Good | 24 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 12 | Not Satisfied | 8 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 7 | Excellent | 15 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 7 | Very good | 23 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 7 | Good | 20 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 7 | Satisfactory | 7 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 7 | Not Satisfied | 12 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 9 | Excellent | 23 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 9 | Very good | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 9 | Good | 24 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 9 | Satisfactory | 11 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 9 | Not Satisfied | 8 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 12 | Excellent | 20 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 12 | Very good | 16 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 12 | Good | 32 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 12 | Satisfactory | 9 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 12 | Not Satisfied | 11 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 7 | Excellent | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 7 | Very Good | 20 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 7 | Good | 17 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 7 | Satisfactory | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 7 | Not Satisfied | 4 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 9 | Excellent | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 9 | Very Good | 28 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 9 | Good | 22 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 9 | Satisfactory | 10 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 9 | Not Satisfied | 7 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 12 | Excellent | 21 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 12 | Very Good | 23 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 12 | Good | 27 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 12 | Satisfactory | 11 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 12 | Not Satisfied | 6 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 7 | Excellent | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 7 | Very good | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 7 | Good | 16 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 7 | Satisfactory | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 7 | Not Satisfied | 5 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 9 | Excellent | 17 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 9 | Very good | 26 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 9 | Good | 21 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 9 | Satisfactory | 15 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 9 | Not Satisfied | 6 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 12 | Excellent | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 12 | Very good | 21 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 12 | Good | 28 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 12 | Satisfactory | 13 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 12 | Not Satisfied | 7 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 7 | Excellent | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 7 | Very good | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 7 | Good | 12 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 7 | Satisfactory | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 7 | Not Satisfied | 10 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 9 | Excellent | 21 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 9 | Very good | 22 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 9 | Good | 22 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 9 | Satisfactory | 14 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 9 | Not Satisfied | 6 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 12 | Excellent | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 12 | Very good | 20 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 12 | Good | 25 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 12 | Satisfactory | 17 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 12 | Not Satisfied | 7 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 7 | Excellent | 13 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 7 | Very good | 24 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 7 | Good | 15 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 7 | Satisfactory | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 7 | Not satisfied | 6 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 9 | Excellent | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 9 | Very good | 26 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 9 | Good | 18 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 9 | Satisfactory | 15 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 9 | Not satisfied | 7 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 12 | Excellent | 15 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 12 | Very good | 29 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 12 | Good | 24 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 12 | Satisfactory | 11 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 12 | Not satisfied | 9 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 7 | Good | 19 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 7 | Excellent | 16 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 7 | Very good | 23 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 7 | Satisfactory | 12 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 7 | Not satisfied | 7 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 9 | Excellent | 23 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 9 | Very good | 26 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 9 | Good | 16 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 9 | Satisfactory | 14 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 9 | Not satisfied | 6 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 12 | Excellent | 23 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 12 | Very good | 21 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 12 | Good | 23 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 12 | Satisfactory | 14 Participants |
| Control Group: No-treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 12 | Not satisfied | 7 Participants |
Secondary
Subject Satisfaction: Would You do the Treatment Again?
A subject satisfaction question with responses Yes or No.
Time frame: At Month 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluated for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: No-treatment | Subject Satisfaction: Would You do the Treatment Again? | Yes | 76 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You do the Treatment Again? | No | 12 Participants |
Secondary
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
A subject satisfaction question with responses Yes or No.
Time frame: At Month 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: No-treatment | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | Yes | 78 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | No | 10 Participants |
Secondary
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 7 | Strongly agree | 47 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 7 | Agree | 25 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 7 | Neither Agree or Disagree | 4 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 7 | Disagree | 1 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 7 | Strongly Disagree | 0 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 9 | Strongly agree | 48 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 9 | Agree | 25 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 9 | Neither Agree or Disagree | 11 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 9 | Disagree | 0 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 9 | Strongly Disagree | 1 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 12 | Strongly agree | 47 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 12 | Agree | 30 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 12 | Neither Agree or Disagree | 7 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 12 | Disagree | 2 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 12 | Strongly Disagree | 2 Participants |
Secondary
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.
Time frame: At Months 7, 9, and 12
Population: ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 7 | Neither agree or Disagree | 11 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 7 | Disagree | 2 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 7 | Strongly disagree | 1 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 7 | Strongly agree | 36 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 7 | Agree | 27 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 9 | Strongly agree | 41 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 9 | Agree | 27 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 9 | Neither agree or Disagree | 13 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 9 | Disagree | 1 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 9 | Strongly disagree | 3 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 12 | Strongly agree | 41 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 12 | Agree | 31 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 12 | Neither agree or Disagree | 12 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 12 | Disagree | 2 Participants |
| Control Group: No-treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 12 | Strongly disagree | 2 Participants |