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

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

Study Overview

• Status: Completed
• Conditions: Midface Volume Deficit
• Intervention / Treatment: Device: Sculptra

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.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Galderma research site 3
  • Beijing, China
    • Galderma research site 4
  • Chengdu, China
    • Galderma research site 5
  • Guangzhou, China
    • Galderma research site 2
  • Hangzhou, China
    • Galderma research site 6
  • Shanghai, China
    • Galderma research site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Sculptra; 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.	Device: Sculptra; Initial injection and optional 3 injections with Sculptra in Midface.
Experimental: Group B: Sculptra; 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.	Device: Sculptra; Initial injection and optional 3 injections with Sculptra in Midface.
No Intervention: Group B: Control; Participants in Group B will not receive any treatment and participants will be followed up for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.; Fairly full midface; Mild loss of fullness in midface area; Moderate loss of fullness with slight hollowing below malar prominence; Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence	Baseline, Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.; Fairly full midface; Mild loss of fullness in midface area; Moderate loss of fullness with slight hollowing below malar prominence; Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence	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.; Fairly full midface; Mild loss of fullness in midface area; Moderate loss of fullness with slight hollowing below malar prominence; Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence	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

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Galderma, Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): July 18, 2021
• Study Completion (Actual): July 18, 2022

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: PLLA; Midface Volume Deficit
• Other Study ID Numbers: 43CHSA1803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No