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RecruitingNCT07891767Updated Oct 23, 2026

A Study to Evaluate the Long-term Safety and Effectiveness of Sculptra™

An observational study in Midface Volume Deficit and Midface Contour Deficiency, sponsored by Galderma R&D. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Galderma R&D (part of Galderma Group AG) · Observational

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Midface Volume Deficit
  • Midface Contour Deficiency
03

In context

Lead sponsor

Galderma R&D is the lead sponsor of 283 studies on the registry; 10 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Men or women aged 18 years or older of Chinese origin.
  2. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Received treatment with semi-permanent filler in the midface within 1 year before the first Sculptra treatment in the midface up to Day 1.
  3. Received treatment with permanent filler in the midface.
  4. Participation in any other clinical study within 30 days before Day 1.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
300 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Subjects treated with Sculptra in the midface 11-12 months before screening.
06

What researchers measure

Primary outcomes

  1. 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.

  2. Incidence, intensity, duration, and onset of related AEs detected during focused physical examinations.

    Time frame: At Day 1 and Month 12

  3. Incidence, intensity and duration of pre-defined symptoms collected using a Subject Complaint Questionnaire

    Time frame: At Day 1, Month 6 and Month 12

  4. Percentage of subjects in each response category for the Subjects Safety Satisfaction Questionnaire

    Time frame: At Day 1, Month 6 and Month 12

  5. 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

  6. 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

  7. 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

07

Study locations

1 of 1 sites recruiting
  • Dermatology Hospital of Southern Medical University
    Guangzhou, China
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07891767
Lead sponsor
Galderma R&D
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Oct 23, 2026

Study contacts

Galderma Research & Development
Contact
Clinical.Studies@galderma.com
+8621 23159790
Galderma S.A.
study director · Galderma S.A.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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