Midface Volume DeficitNCT04132518
Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
A study testing Sculptra in people with Midface Volume Deficit, run by Galderma R&D at 6 sites in China.
Trial summary
This is a randomized, evaluator-blinded, no-treatment controlled study in participants with Midface Volume Deficit and/or Midface Contour Deficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Midface Volume Deficit
- What is being tested?
- Sculptra
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 6 sitesChina
- Study dates
- 12 Nov 2019to 18 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent to participate in the study.
- Men or women aged 18 years of age or older of Chinese origin.
- Participants seeking augmentation therapy for the midface.
- MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator.
Who cannot join
- Known/previous allergy or hypersensitivity to any of the constituents of the product.
- Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
- History of severe or multiple allergies, such as anaphylaxis.
- 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.
- Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
- 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.
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Galderma research site 3
Beijing
Galderma research site 4
Beijing
Galderma research site 5
Chengdu
Galderma research site 2
Guangzhou
Galderma research site 6
Hangzhou
Galderma research site 1
Shanghai
About this study
Official title: 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.
Read the 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.
- Conditions
- Midface Volume Deficit
- Being tested
- Sculptra
- Keywords
- PLLA, Midface Volume Deficit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SculptraDevice
Initial injection and optional 3 injections with Sculptra in Midface.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sculptra |
| 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. Receives: Device: Sculptra |
| Group B: Control | No intervention | Participants in Group B will not receive any treatment and participants will be followed up for 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Month 12
Secondary outcomes (15)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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.
Measured: 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?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?
Measured: 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?
Measured: Treatment group: Months 6, 9, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start12 Nov 2019
- Primary completion18 Jul 2021
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Midface Volume DeficitStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Galderma, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132518
- Sponsor's protocol ID
- 43CHSA1803
- Status last verified
- Jan 2024
- First submitted
- 15 Oct 2019
- Last updated
- 7 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04132518
- Acronym / sponsor ID
- 43CHSA1803
- Conditions
- Midface Volume Deficit
- Keywords
- PLLA, Midface Volume Deficit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 18 Jul 2021 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Sculptra | Experimental | Device: SculptraParticipants 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 | Device: SculptraParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated informed consent to participate in the study.
- Men or women aged 18 years of age or older of Chinese origin.
- Participants seeking augmentation therapy for the midface.
- MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator.
Key exclusion criteria (7 listed)
- Known/previous allergy or hypersensitivity to any of the constituents of the product.
- Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
- History of severe or multiple allergies, such as anaphylaxis.
- 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.
- Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SculptraInitial injection and optional 3 injections with Sculptra in Midface. | Device | Group A: Sculptra, Group B: Sculptra |
Primary outcome
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
Time frame: 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
15 secondary outcomes
Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Treatment group: Months 6, 9, 12, 18 and 24
Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural
Time frame: 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
Time frame: 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"
Time frame: Treatment group: Months 6, 9, 12, 18 and 24
Percentage of Participants Agreeing That They Feel More Attractive by the Treatment
Time frame: Treatment group: Months 6, 9, 12, 18 and 24
Percentage of Participants Agreeing That They Feel Better by the Treatment
Time frame: Treatment group: Months 6, 9, 12, 18 and 24
Percentage of Participants Agreeing That They Are Satisfied by the Treatment
Time frame: Treatment group: Months 6, 9, 12, 18 and 24
Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues
Time frame: Treatment group: Months 6, 9, 12, 18 and 24
Percentage of Participants Who Recommended This Treatment to Their Friends
Time frame: Treatment group: Months 6, 9, 12, 18 and 24
Percentage of Participants Who Liked to Receive the Same Treatment Again
Time frame: Treatment group: Months 6, 9, 12, 18 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galderma study director
Galderma R&D
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sculptra in people with Midface Volume Deficit, run by Galderma R&D at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.