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Effectiveness and Safety of STYLAGE® HYDRO in the Treatment of Face, Neckline Area and Neck — FLASH  

Aging Clinical Trial

Official title:
FLASH Study: Effectiveness and Safety of STYLAGE® HYDRO in the Treatment of Face, Neckline Area and Neck

Clinical Trial Summary

FLASH Study is a Post-Market Follow-Up PCMF designed to evaluate the tolerance and efficacy of STYLAGE Hydro by using a satisfaction questionnaire.

Clinical Trial Description

This is a prospective, in open, single arm and multicentric study designed to evaluate the tolerance and efficacy of STYLAGE Hydro. Patients will be injected up to 2 mL of STYLAGE Hydro per area at each session. Three injection sessions 2 weeks apart are planned: one at visit 1 (D0), one at visit 2 (W2) and one at visit 3 (W4). Proportions of subjects who are satisfied on the face 6 weeks after treatment initiation will be assessed. For each question of the questionnaire, the subjects who are satisfied are defined as subjects who rated "Somewhat agree", "Agree" or "Totally agree". Global aesthetic improvement according to independent evaluator and subjects' satisfaction will also be done during other visits. Safety parameters will be evaluated during the study period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05809739
Study type Interventional
Source Laboratoires Vivacy
Contact
Status Completed
Phase N/A
Start date February 28, 2023
Completion date February 1, 2024
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