Midface Volume DeficitNCT07891767
A Study to Evaluate the Long-term Safety and Effectiveness of Sculptra™
An observational study of Midface Volume Deficit and Midface Contour Deficiency, run by Galderma R&D at 1 site in China.
Trial summary
This is a non-interventional, multi-center, study designed to evaluate the long-term safety and effectiveness of Sculptra™ for the correction of midface volume deficit and/or midface contour deficiency in subjects of Chinese origin in standard clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Midface Volume Deficit, Midface Contour Deficiency
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Apr 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Subjects aged 18 years or older, and who received Sculptra treatment in the midface, within the last 11-12 months, prior to screening.
Who may be able to join
- Men or women aged 18 years or older of Chinese origin.
- Subjects who, independently of this study, received initial Sculptra treatment in the midface, with or without other facial areas, 11-12 months before screening, with relevant treatment records retained by the clinic.
Who cannot join
- Received any other sort of hyaluronic acid fillers and collagen-based filler in the midface within 1 year after the first Sculptra treatment in the midface.
- Received treatment with semi-permanent filler in the midface within 1 year before the first Sculptra treatment in the midface up to Day 1.
- Received treatment with permanent filler in the midface.
- Participation in any other clinical study within 30 days before Day 1.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dermatology Hospital of Southern Medical University
Guangzhou
Galderma Investigational Site #6424, +862083027571, yangbin101@hotmail.com
About this study
Official title: A Non-interventional, Multi-center Study to Evaluate the Long-term Safety and Effectiveness of Sculptra™ for the Correction of Midface Volume Deficit and/or Midface Contour Deficiency in the Chinese Population
This is a non-interventional, multi-center, study designed to evaluate the long-term safety and effectiveness of Sculptra™ for the correction of midface volume deficit and/or midface contour deficiency in subjects of Chinese origin in standard clinical practice.
Read the detailed description
The total duration of the study is estimated to be approximately 19 months (not including 12 months of retrospective period).
Effectiveness and safety data will be collected for up to 24 months after the initial treatment, including 12 months of retrospective period and another 12 months of prospective period.
- Conditions
- Midface Volume Deficit, Midface Contour Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with Sculptra in the midface 11-12 months before screening. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, intensity, duration, and onset of related adverse events (AEs) collected from medical records since first treatment
Measured: From the subject's first midface Sculptra treatment to the end of the study, 24 months after the first treatment.
Incidence, intensity, duration, and onset of related AEs detected during focused physical examinations.
Measured: At Day 1 and Month 12
Incidence, intensity and duration of pre-defined symptoms collected using a Subject Complaint Questionnaire
Measured: At Day 1, Month 6 and Month 12
Percentage of subjects in each response category for the Subjects Safety Satisfaction Questionnaire
Measured: At Day 1, Month 6 and Month 12
Percentage of responders, defined by having "Improved", "Much improved" or "Very much improved" according to the Global Aesthetic Improvement Scale (GAIS) on both sides of the face combined, as assessed by the subject and the investigator
Measured: At Day 1 and Month 12
Percentage of subjects in each response category for each question in the Subject Effectiveness Satisfaction Questionnaire
Measured: At Day 1, Month 6 and Month 12
Percentage of subjects in each response category for each question in the Skin Quality Improvement Questionnaire
Measured: At Day 1, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midface Volume DeficitStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Galderma S.A., Study director, Galderma S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891767
- Sponsor's protocol ID
- 05DF2502
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Multi-center Study to Evaluate the Long-term Safety and Effectiveness of Sculptra™ for the Correction of Midface Volume Deficit and/or Midface Contour Deficiency in the Chinese Population
- ClinicalTrials.gov ID
- NCT07891767
- Acronym / sponsor ID
- 05DF2502
- Conditions
- Midface Volume Deficit, Midface Contour Deficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
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 non-interventional, multi-center, study designed to evaluate the long-term safety and effectiveness of Sculptra™ for the correction of midface volume deficit and/or midface contour deficiency in subjects of Chinese origin in standard clinical practice.
Detailed description
The total duration of the study is estimated to be approximately 19 months (not including 12 months of retrospective period).
Effectiveness and safety data will be collected for up to 24 months after the initial treatment, including 12 months of retrospective period and another 12 months of prospective period.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with Sculptra in the midface 11-12 months before screening. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged 18 years or older, and who received Sculptra treatment in the midface, within the last 11-12 months, prior to screening.
Key inclusion criteria (2 listed)
- Men or women aged 18 years or older of Chinese origin.
- Subjects who, independently of this study, received initial Sculptra treatment in the midface, with or without other facial areas, 11-12 months before screening, with relevant treatment records retained by the clinic.
Key exclusion criteria (4 listed)
- Received any other sort of hyaluronic acid fillers and collagen-based filler in the midface within 1 year after the first Sculptra treatment in the midface.
- Received treatment with semi-permanent filler in the midface within 1 year before the first Sculptra treatment in the midface up to Day 1.
- Received treatment with permanent filler in the midface.
- Participation in any other clinical study within 30 days before Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence, intensity, duration, and onset of related adverse events (AEs) collected from medical records since first treatment
Time frame: From the subject's first midface Sculptra treatment to the end of the study, 24 months after the first treatment.
Incidence, intensity, duration, and onset of related AEs detected during focused physical examinations.
Time frame: At Day 1 and Month 12
Incidence, intensity and duration of pre-defined symptoms collected using a Subject Complaint Questionnaire
Time frame: At Day 1, Month 6 and Month 12
Percentage of subjects in each response category for the Subjects Safety Satisfaction Questionnaire
Time frame: At Day 1, Month 6 and Month 12
Percentage of responders, defined by having "Improved", "Much improved" or "Very much improved" according to the Global Aesthetic Improvement Scale (GAIS) on both sides of the face combined, as assessed by the subject and the investigator
Time frame: At Day 1 and Month 12
Percentage of subjects in each response category for each question in the Subject Effectiveness Satisfaction Questionnaire
Time frame: At Day 1, Month 6 and Month 12
Percentage of subjects in each response category for each question in the Skin Quality Improvement Questionnaire
Time frame: At Day 1, Month 6 and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Related trials for Midface Volume Deficit
Recruiting
Safety and Effectiveness of Mosaic for the Treatment of Midface Volume Deficit
Midface Volume Deficit
Recruiting
THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
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.
Galderma S.A. study director
Galderma S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Midface Volume Deficit and Midface Contour Deficiency, run by Galderma R&D at 1 site 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galderma Research & Development (+8621 23159790, Clinical.Studies@galderma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, intensity, duration, and onset of related adverse events (AEs) collected from medical records since first treatment (time frame: From the subject's first midface Sculptra treatment to the end of the study, 24 months after the first treatment.). The study lists 7 primary outcomes in all. 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 23 Oct 2026.