NCT06142578

Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices

Safety and Effectiveness Clinical Evaluation of the Range of Injectable Medical Devices Fillgel in Facial Aesthetic Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Kylane Laboratoires · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study aims to confirm the safety and effectiveness of FILLGEL devices

Detailed description

The primary objective is to evaluate the effectiveness of the FILLGEL range used on different treated zones one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by the independent investigator. The secondary objectives of the study are to collect data for the FILLGEL range on: * the effectiveness of the range used on different treated zones six months (M6) and twelve months (M12) . * the safety using clinical evaluation of the Injection Site Reactions (ISR) rated by the subject and the investigator. * subject's satisfaction and subject's opinion on aesthetic improvement on the different treated zones. * the injector's satisfaction on the injection quality using subjective evaluation questionnaire.

Conditions

• Aesthetic Dermatology

Interventions

Type	Name	Description
DEVICE	Dermal Filler Device	Injection of device by investigators according to the Instruction For Use (IFU)

Timeline

• Start date: 2022-11-14
• Primary completion: 2023-01-12
• Completion: 2024-01-31
• First posted: 2023-11-21
• Last updated: 2025-04-25
• Results posted: 2025-04-25

Locations

1 site across 1 country: Switzerland