NCT05809739

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Laboratoires Vivacy · Industry
• Sex: Female
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	STYLAGE Hydro	3 sessions of injections (J0, J14 and J28)

Timeline

• Start date: 2023-02-28
• Primary completion: 2023-12-31
• Completion: 2024-02-01
• First posted: 2023-04-12
• Last updated: 2024-02-16

Locations

2 sites across 1 country: France