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This is a randomized, evaluator-blinded, no-treatment controlled study in participants with Midface Volume Deficit and/or Midface Contour Deficiency.
For Group A, after screening, eligible participants will be treated from day 1 and followed up for 24 months. The purpose of Group A was to confirm investigator's use of correct injection technique.
For Group B, the study includes two phases as follows:
Main study phase: It is randomized, evaluator-blinded and no-treatment controlled. After screening, all eligible participants will be randomized either to the Treatment Group or the Control Group in a 2:1 ratio. All the participants will be followed up for 12 months.
Extension study phase: After the main study phase, the Treatment Group will be followed up for additional 12 months.
Each subject assigned to Group A and Treatment Group will receive up to 4 injection sessions with 5(±1) weeks intervals.
Participants assigned to the Control Group will not receive treatment during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Sculptra | Experimental | Participants in Group A will receive up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and will be followed up for 24 months. |
|
| Group B: Sculptra | Experimental | Participants in Group B will receive up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and will be followed up for 24 months. |
|
| Group B: Control | No Intervention | Participants in Group B will not receive any treatment and participants will be followed up for 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sculptra | Device | Initial injection and optional 3 injections with Sculptra in Midface. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 1 Point Improvement From Baseline on the Medicis Midface Volume Scale (MMVS) as Measured by the Blinded Evaluator at Month 12 | MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome.
| Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator | MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Galderma | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma research site 3 | Beijing | China | ||||
| Galderma research site 4 |
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A total of 16 participants were enrolled into Group A and 189 participants were enrolled into Group B. Out of 189 participants in Group B, 126 participants randomized in treatment group and 63 participants in control group or no treatment group.
The study was conducted at 6 centers in China from 12 November 2019 to 18 July 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Sculptra | Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months. |
| FG001 | Group B: Sculptra | Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months. |
| FG002 | Group B: Control | Participants in Group B did not receive any treatment and followed up for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Full analysis set (FAS) included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Sculptra | Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months. |
| BG001 | Group B: Sculptra |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With 1 Point Improvement From Baseline on the Medicis Midface Volume Scale (MMVS) as Measured by the Blinded Evaluator at Month 12 | MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome.
| FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Month 12 |
|
From start of study product administration up to 2 years 4 months
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Sculptra | Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytosis | Blood and lymphatic system disorders | 22.0 | Non-systematic Assessment | All SAEs were unrelated to the product and/or the injection procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Development | Q-Med AB | +46184749000 | reception.seupp@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2019 | Oct 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2019 | Oct 24, 2024 | SAP_001.pdf |
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| Treatment group: Baseline, Months 6, 9, 18 and 24; Control group: Baseline, Months 6 and 9 |
| Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator | MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome.
| Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12 |
| Total Volume Change From Baseline Over Time of the Right and Left Midface Areas | Total volume change from baseline over time (both sides of the face combined) was calculated by a digital 3D image analysis. | Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12 |
| Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator | The 5-graded GAIS was used to live assess the aesthetic improvement of the midface fullness of both sides of the participant's face as compared to photographs taken before treatment. Each midface side was rated separately. Rating and its Description:1. Very much improved (Optimal cosmetic result for the implant in this participant), 2. Much improved (Marked improvement in appearance from the original condition),3. Improved (Obvious improvement in appearance from the original condition), 4. No change (The appearance is essentially the same as original condition), 5. Worse (The appearance is worse than the original condition). Responders are those with a rating of at least improved. Participants with a GAIS rating of 'Very much improved', 'Much improved', or 'Improved' are defined as responders. Percentage of responders," according to the GAIS on both sides of the face combined, as assessed by the Treating Investigator was reported. | Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12 |
| Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant | The 5-graded GAIS was used to live assess the aesthetic improvement of the midface fullness of both sides of the participant's face as compared to photographs taken before treatment. Each midface side was rated separately. Rating and its Description: 1. Very much improved (Optimal cosmetic result for the implant in this participant), 2. Much improved (Marked improvement in appearance from the original condition),3. Improved (Obvious improvement in appearance from the original condition), 4. No change (The appearance is essentially the same as original condition), 5. Worse (The appearance is worse than the original condition). Responders are those with a rating of at least improved. Participants with a GAIS rating of 'Very much improved', 'Much improved', or 'Improved' are defined as responders. Percentage of responders," according to the GAIS on both sides of the face combined, as assessed by the Participant was reported. | Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12 |
| Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 1 was a YES or NO question pertaining to satisfaction with study treatment: Do you think your Cheek Volume deficit and/or Contour Deficiency has been improved with the treatment? | Treatment group: Months 6, 9, 12, 18 and 24 |
| Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 2 was a YES or NO question pertaining to naturalness of the study treatment: Do you think that the overall result of the treatment looks natural? | Treatment group: Months 6, 9, 12, 18 and 24 |
| Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 3 was answered on a 4-grade scale: Would you say that the study treatment: Surpass your expectations/Meet your expectations/ Do Meet your expectations/You did not have any specific expectations before the injections? | Treatment group: Months 6, 9, 12, 18 and 24 |
| Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence" | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 4 was a yes or no question: Do you think that the treatment brings you more: Youth/Beauty/Harmony/Symmetrical appearance/Pep/Liveliness/Freshened look/Self-esteem/confidence. | Treatment group: Months 6, 9, 12, 18 and 24 |
| Percentage of Participants Agreeing That They Feel More Attractive by the Treatment | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 5 was a yes or no question: Would you say that you feel more attractive? | Treatment group: Months 6, 9, 12, 18 and 24 |
| Percentage of Participants Agreeing That They Feel Better by the Treatment | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 6 was answered on a 5-grade scale: How do you feel about yourself since the treatment was performed? Very much better / Much better / Somewhat better / The same / Worse. Percentage of participants who responded Very much better / Much better / Somewhat better were reported in this outcome measure. | Treatment group: Months 6, 9, 12, 18 and 24 |
| Percentage of Participants Agreeing That They Are Satisfied by the Treatment | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 7 was answered on a 4-grade scale: Overall, how satisfied are you with the treatment result? Very satisfied/ Satisfied/ Somewhat satisfied/ Not satisfied. | Treatment group: Months 6, 9, 12, 18 and 24 |
| Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 8: Did you get any feedback about your look from your family, friends and colleagues? Positive/Negative/No feedback. | Treatment group: Months 6, 9, 12, 18 and 24 |
| Percentage of Participants Who Recommended This Treatment to Their Friends | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 9 was a yes or no question: Would you recommend this treatment to friends? | Treatment group: Months 6, 9, 12, 18 and 24 |
| Percentage of Participants Who Liked to Receive the Same Treatment Again | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 10 was a yes or no question: Would you like to receive the same treatment again? | Treatment group: Months 6, 9, 12, 18 and 24 |
| Beijing |
| China |
| Galderma research site 5 | Chengdu | China |
| Galderma research site 2 | Guangzhou | China |
| Galderma research site 6 | Hangzhou | China |
| Galderma research site 1 | Shanghai | China |
Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months.
| BG002 | Group B: Control | Participants in Group B did not receive any treatment and followed up for 12 months. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 | Group A: Sculptra | Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months. |
| OG001 | Group B: Sculptra | Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months. |
| OG002 | Group B: Control | Participants in Group B did not receive any treatment and followed up for 12 months. |
|
|
| Secondary | Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator | MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome.
| Full analysis set (FAS) included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. | Posted | Number | 95% Confidence Interval | Percentage of participants | Treatment group: Baseline, Months 6, 9, 18 and 24; Control group: Baseline, Months 6 and 9 |
|
|
|
| Secondary | Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator | MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome.
| FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. | Posted | Number | 95% Confidence Interval | Percentage of participants | Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12 |
|
|
|
| Secondary | Total Volume Change From Baseline Over Time of the Right and Left Midface Areas | Total volume change from baseline over time (both sides of the face combined) was calculated by a digital 3D image analysis. | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. | Posted | Mean | Standard Deviation | milliliter (mL) | Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12 |
|
|
|
| Secondary | Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator | The 5-graded GAIS was used to live assess the aesthetic improvement of the midface fullness of both sides of the participant's face as compared to photographs taken before treatment. Each midface side was rated separately. Rating and its Description:1. Very much improved (Optimal cosmetic result for the implant in this participant), 2. Much improved (Marked improvement in appearance from the original condition),3. Improved (Obvious improvement in appearance from the original condition), 4. No change (The appearance is essentially the same as original condition), 5. Worse (The appearance is worse than the original condition). Responders are those with a rating of at least improved. Participants with a GAIS rating of 'Very much improved', 'Much improved', or 'Improved' are defined as responders. Percentage of responders," according to the GAIS on both sides of the face combined, as assessed by the Treating Investigator was reported. | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. | Posted | Number | 95% Confidence Interval | Percentage of responders | Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12 |
|
|
|
| Secondary | Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant | The 5-graded GAIS was used to live assess the aesthetic improvement of the midface fullness of both sides of the participant's face as compared to photographs taken before treatment. Each midface side was rated separately. Rating and its Description: 1. Very much improved (Optimal cosmetic result for the implant in this participant), 2. Much improved (Marked improvement in appearance from the original condition),3. Improved (Obvious improvement in appearance from the original condition), 4. No change (The appearance is essentially the same as original condition), 5. Worse (The appearance is worse than the original condition). Responders are those with a rating of at least improved. Participants with a GAIS rating of 'Very much improved', 'Much improved', or 'Improved' are defined as responders. Percentage of responders," according to the GAIS on both sides of the face combined, as assessed by the Participant was reported. | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. | Posted | Number | 95% Confidence Interval | Percentage of responders | Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12 |
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|
|
| Secondary | Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 1 was a YES or NO question pertaining to satisfaction with study treatment: Do you think your Cheek Volume deficit and/or Contour Deficiency has been improved with the treatment? | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group. | Posted | Number | percentage of participants | Treatment group: Months 6, 9, 12, 18 and 24 |
|
|
|
| Secondary | Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 2 was a YES or NO question pertaining to naturalness of the study treatment: Do you think that the overall result of the treatment looks natural? | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group. | Posted | Number | percentage of participants | Treatment group: Months 6, 9, 12, 18 and 24 |
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| Secondary | Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 3 was answered on a 4-grade scale: Would you say that the study treatment: Surpass your expectations/Meet your expectations/ Do Meet your expectations/You did not have any specific expectations before the injections? | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group. | Posted | Number | percentage of participants | Treatment group: Months 6, 9, 12, 18 and 24 |
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| Secondary | Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence" | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 4 was a yes or no question: Do you think that the treatment brings you more: Youth/Beauty/Harmony/Symmetrical appearance/Pep/Liveliness/Freshened look/Self-esteem/confidence. | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group. | Posted | Number | percentage of participants | Treatment group: Months 6, 9, 12, 18 and 24 |
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|
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| Secondary | Percentage of Participants Agreeing That They Feel More Attractive by the Treatment | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 5 was a yes or no question: Would you say that you feel more attractive? | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group. | Posted | Number | percentage of participants | Treatment group: Months 6, 9, 12, 18 and 24 |
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| Secondary | Percentage of Participants Agreeing That They Feel Better by the Treatment | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 6 was answered on a 5-grade scale: How do you feel about yourself since the treatment was performed? Very much better / Much better / Somewhat better / The same / Worse. Percentage of participants who responded Very much better / Much better / Somewhat better were reported in this outcome measure. | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group. | Posted | Number | percentage of participants | Treatment group: Months 6, 9, 12, 18 and 24 |
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| Secondary | Percentage of Participants Agreeing That They Are Satisfied by the Treatment | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 7 was answered on a 4-grade scale: Overall, how satisfied are you with the treatment result? Very satisfied/ Satisfied/ Somewhat satisfied/ Not satisfied. | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group. | Posted | Number | percentage of participants | Treatment group: Months 6, 9, 12, 18 and 24 |
|
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| Secondary | Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 8: Did you get any feedback about your look from your family, friends and colleagues? Positive/Negative/No feedback. | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group. | Posted | Number | percentage of participants | Treatment group: Months 6, 9, 12, 18 and 24 |
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| Secondary | Percentage of Participants Who Recommended This Treatment to Their Friends | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 9 was a yes or no question: Would you recommend this treatment to friends? | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group. | Posted | Number | percentage of participants | Treatment group: Months 6, 9, 12, 18 and 24 |
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| Secondary | Percentage of Participants Who Liked to Receive the Same Treatment Again | The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 10 was a yes or no question: Would you like to receive the same treatment again? | FAS included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints. Data was planned to be analyzed and collected only for treatment group. | Posted | Number | percentage of participants | Treatment group: Months 6, 9, 12, 18 and 24 |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| 10 |
| 16 |
| EG001 | Group B: Sculptra | Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months. | 0 | 124 | 7 | 124 | 15 | 124 |
| EG002 | Group B: Control | Participants in Group B did not receive any treatment and followed up for 12 months. | 0 | 63 | 0 | 63 | 4 | 63 |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 22.0 | Non-systematic Assessment | All SAEs were unrelated to the product and/or the injection procedure. |
|
| Ovarian cyst | Reproductive system and breast disorders | 22.0 | Non-systematic Assessment | All SAEs were unrelated to the product and/or the injection procedure. |
|
| Removal of internal fixation | Surgical and medical procedures | 22.0 | Non-systematic Assessment | All SAEs were unrelated to the product and/or the injection procedure. |
|
| Basedow's disease | Surgical and medical procedures | 22.0 | Non-systematic Assessment | All SAEs were unrelated to the product and/or the injection procedure. |
|
| Gallbladder polyp | Hepatobiliary disorders | 22.0 | Non-systematic Assessment | All SAEs were unrelated to the product and/or the injection procedure. |
|
| Cardiac neoplasm unspecific | Cardiac disorders | 22.0 | Non-systematic Assessment | All SAEs were unrelated to the product and/or the injection procedure. |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 22.0 | Non-systematic Assessment | All SAEs were unrelated to the product and/or the injection procedure. |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Non-systematic Assessment | All SAEs were unrelated to the product and/or the injection procedure. |
|
| Implant site nodule | General disorders | 22.0 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | 22.0 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | 22.0 | Non-systematic Assessment |
|
| Xerophthalmia | Eye disorders | 22.0 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
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| Tooth disorder | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
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| Asthenia | General disorders | 22.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | 22.0 | Non-systematic Assessment |
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| Gallbladder polyp | Hepatobiliary disorders | 22.0 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | 22.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | 22.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | 22.0 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | 22.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | 22.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | 22.0 | Non-systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | 22.0 | Non-systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | 22.0 | Non-systematic Assessment |
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| Calcium deficiency | Metabolism and nutrition disorders | 22.0 | Non-systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | 22.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 22.0 | Non-systematic Assessment |
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| Synovitis | Musculoskeletal and connective tissue disorders | 22.0 | Non-systematic Assessment |
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| Cervix disorder | Reproductive system and breast disorders | 22.0 | Non-systematic Assessment |
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| Menopausal symptoms | Reproductive system and breast disorders | 22.0 | Non-systematic Assessment |
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| Menstrual disorder | Reproductive system and breast disorders | 22.0 | Non-systematic Assessment |
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| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | 22.0 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | 22.0 | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
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| Alopecia areata | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
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| Skin fissures | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
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| Arteriosclerosis | Vascular disorders | 22.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | 22.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
|
The initial publication of data from the Study must be a multi-center publication. Any subsequent publication/presentation must be sent to Sponsor for review 60 days before submission for publication/presentation to allow Sponsor to protect patentable inventions/confidential information. Site and Investigator agree to amend proposed publication/presentation, remove such confidential information from it, or postpone submission for a further 60 days/until intellectual property filings take place.
| At Month 9 |
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| At Month 18 |
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| At Month 24 |
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| At Month 9 |
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| At Month 12 |
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| At Month 18 |
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| At Month 24 |
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Month 9 |
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| Months 12 |
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| Month 18 |
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| Month 24 |
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Month 6: Surpass your expectations |
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| Month 9: Meet your expectations |
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| Month 9: Surpass your expectations |
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| Month 12: Meet your expectations |
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| Month 12: Surpass your expectations |
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| Month 18: Meet your expectations |
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| Month 18: Surpass your expectations |
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| Month 24: Meet your expectations |
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| Month 24: Surpass your expectations |
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| Month 6 : Beauty |
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| Month 6 : Harmony |
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| Month 6 : Symmetrical appearance |
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| Month 6 : Pep/Liveliness /Freshened look |
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| Month 6 : Selfesteem/ confidence |
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| Month 9: Youth |
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| Month 9 : Beauty |
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| Month 9 : Harmony |
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| Month 9: Symmetrical appearance |
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| Month 9: Pep/Liveliness /Freshened look |
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| Month 9 : Selfesteem/ confidence |
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| Month 12: Youth |
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| Month 12 : Beauty |
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| Month 12 : Harmony |
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| Month 12: Symmetrical appearance |
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| Month 12 : Pep/Liveliness /Freshened look |
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| Month 12: Selfesteem/ confidence |
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| Month 18: Youth |
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| Month 18 : Beauty |
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| Month 18 : Harmony |
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| Month 18 : Symmetrical appearance |
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| Month 18: Pep/Liveliness /Freshened look |
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| Month 18: Selfesteem/ confidence |
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| Month 24 : Youth |
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| Month 24 : Beauty |
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| Month 24 : Harmony |
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| Month 24 : Symmetrical appearance |
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| Month 24 : Pep/Liveliness /Freshened look |
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| Month 24 : Selfesteem/ confidence |
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| Month 9: Yes |
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| Month 12 : Yes |
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| Month 18: Yes |
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| Month 24 : Yes |
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| Month 6 : Much better |
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| Month 6 : Somewhat better |
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| Month 9 : Very much better |
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| Month 9 : Much better |
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| Month 9 : Somewhat better |
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| Month 12 : Very much better |
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| Month 12 : Much better |
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| Month 12 : Somewhat better |
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| Month 18 : Very much better |
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| Month 18 : Much better |
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| Month 18: Somewhat better |
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| Month 24 : Very much better |
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| Month 24 : Much better |
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| Month 24 : Somewhat better |
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| Month 6 : Satisfied |
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| Month 6 : Very satisfied |
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| Month 9 : Somewhat satisfied |
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| Month 9 : Satisfied |
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| Month 9: Very satisfied |
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| Month 12: Somewhat satisfied |
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| Month 12 : Satisfied |
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| Month 12: Very satisfied |
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| Month 18: Somewhat satisfied |
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| Month 18 : Satisfied |
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| Month 18: Very satisfied |
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| Month 24 : Somewhat satisfied |
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| Month 24 : Satisfied |
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| Month 24 : Very satisfied |
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Month 9: Yes |
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| Month 12 : Yes |
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| Month 18: Yes |
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| Month 24 : Yes |
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