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

NCT07891767 | Recruiting

• 1 other identifier: 05DF2502
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Midface Volume Deficit; Midface Contour Deficiency

Outcome Measures

Primary Outcomes (7)

• Incidence, intensity, duration, and onset of related adverse events (AEs) collected from medical records since first treatment

  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.

  At Day 1 and Month 12

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

  At Day 1, Month 6 and Month 12

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

  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

  At Day 1 and Month 12

• Percentage of subjects in each response category for each question in the Subject Effectiveness Satisfaction Questionnaire

  At Day 1, Month 6 and Month 12

• Percentage of subjects in each response category for each question in the Skin Quality Improvement Questionnaire

  At Day 1, Month 6 and Month 12

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Dermatology Hospital of Southern Medical University

Guangzhou, China

RECRUITING

Study Officials

• Galderma S.A.

  Galderma S.A.

  STUDY DIRECTOR

Central Study Contacts

Galderma Research & Development

CONTACT

+8621 23159790; Clinical.Studies@galderma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-09

Locations

CN (1)