Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

Midface Volume Deficit Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Midface Volume Deficit and/or Midface Contour Deficiency.

Clinical Trial Description

For Group A, after screening, eligible subjects will be treated from day 1 and followed up for 24 months.

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 subjects will be randomized either to the Treatment Group or the Control Group in a 2:1 ratio. All the subjects 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.

Subjects assigned to the Control Group will not receive treatment during the study. ;

Related Conditions & MeSH terms

• Midface Volume Deficit

• NCT number: NCT04132518
• Study type: Interventional
• Source: Q-Med AB
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 14, 2019
• Completion date: April 30, 2022