NCT04132518

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Midface Volume Deficit

Interventions

Type	Name	Description
DEVICE	Sculptra	Initial injection and optional 3 injections with Sculptra in Midface.

Timeline

• Start date: 2019-11-12
• Primary completion: 2021-07-18
• Completion: 2022-07-18
• First posted: 2019-10-18
• Last updated: 2025-01-07
• Results posted: 2024-12-19

Locations

6 sites across 1 country: China