Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04132518

Enrollment

205

Registered

2019-10-18

Start date

2019-11-12

Completion date

2022-07-18

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Midface Volume Deficit

Keywords

PLLA, Midface Volume Deficit

Brief summary

This is a randomized, evaluator-blinded, no-treatment controlled study in participants with Midface Volume Deficit and/or Midface Contour Deficiency.

Detailed description

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.

Interventions

DEVICESculptra

Initial injection and optional 3 injections with Sculptra in Midface.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Signed and dated informed consent to participate in the study. 2. Men or women aged 18 years of age or older of Chinese origin. 3. Participants seeking augmentation therapy for the midface. 4. MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator.

Exclusion criteria

1. Known/previous allergy or hypersensitivity to any of the constituents of the product. 2. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics. 3. History of severe or multiple allergies, such as anaphylaxis. 4. Previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the area to be treated within 6 months before treatment. 5. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated. 6. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant in the area to be treated. 7. Other condition preventing the subject from entering the study in the Investigator's opinion, e.g. participants not likely to avoid other facial cosmetic treatments, participants anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.

Design outcomes

Primary

Measure	Time frame	Description
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	Baseline, 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. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence

Secondary

Measure	Time frame	Description
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator	Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 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. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence
Total Volume Change From Baseline Over Time of the Right and Left Midface Areas	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 (both sides of the face combined) was calculated by a digital 3D image analysis.
Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator	Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12	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.
Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant	Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12	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.
Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment	Treatment group: Months 6, 9, 12, 18 and 24	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?
Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural	Treatment group: Months 6, 9, 12, 18 and 24	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?
Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment	Treatment group: Months 6, 9, 12, 18 and 24	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?
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator	Treatment group: Baseline, Months 6, 9, 18 and 24; Control group: Baseline, Months 6 and 9	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. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence
Percentage of Participants Agreeing That They Feel More Attractive by the Treatment	Treatment group: Months 6, 9, 12, 18 and 24	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?
Percentage of Participants Agreeing That They Feel Better by the Treatment	Treatment group: Months 6, 9, 12, 18 and 24	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.
Percentage of Participants Agreeing That They Are Satisfied by the Treatment	Treatment group: Months 6, 9, 12, 18 and 24	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.
Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues	Treatment group: Months 6, 9, 12, 18 and 24	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.
Percentage of Participants Who Recommended This Treatment to Their Friends	Treatment group: Months 6, 9, 12, 18 and 24	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?
Percentage of Participants Who Liked to Receive the Same Treatment Again	Treatment group: Months 6, 9, 12, 18 and 24	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?
Percentage of Participants Agreeing That Treatment Brings More Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence	Treatment group: Months 6, 9, 12, 18 and 24	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.

Countries

China

Participant flow

Recruitment details

The study was conducted at 6 centers in China from 12 November 2019 to 18 July 2022.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	16
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.	124
Group B: Control Participants in Group B did not receive any treatment and followed up for 12 months.	63
Total	203

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Prematurely withdrawn from the study	0	9	1

Baseline characteristics

Characteristic	Group A: Sculptra	Group B: Sculptra	Group B: Control	Total
Age, Continuous	39.2 years STANDARD_DEVIATION 9.6	41.3 years STANDARD_DEVIATION 10.2	40.5 years STANDARD_DEVIATION 10.7	40.9 years STANDARD_DEVIATION 10.3
Race/Ethnicity, Customized Chinese Han	16 Participants	116 Participants	60 Participants	192 Participants
Race/Ethnicity, Customized Other	0 Participants	8 Participants	3 Participants	11 Participants
Region of Enrollment China	16 Participants	124 Participants	63 Participants	203 Participants
Sex: Female, Male Female	13 Participants	116 Participants	54 Participants	183 Participants
Sex: Female, Male Male	3 Participants	8 Participants	9 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 124	0 / 63
other Total, other adverse events	10 / 16	15 / 124	4 / 63
serious Total, serious adverse events	2 / 16	7 / 124	0 / 63

Outcome results

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. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence

Time frame: Baseline, Month 12

Population: 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.

Arm	Measure	Value (NUMBER)
Group A: Sculptra	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	68.8 Percentage of participants
Group B: Sculptra	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	69.4 Percentage of participants
Group B: Control	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	1.6 Percentage of participants

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?