Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT04132518
Brief 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.
Study:
NCT04132518
Study Brief:
Protocol Section:
NCT04132518