NCT06142643

Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices Viscol

Safety and Effectiveness Clinical Evaluation of Range of Injectable Medical Devices Viscol in Aesthetic Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Kylane Laboratoires · Industry
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Evaluation of safety and performance of HA based injectable device for skin quality improvement

Detailed description

The primary objective is to evaluate the effectiveness of the device used one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent investigator. The secondary objectives of the study are to collect data on: * the effectiveness four months (M4) after treatment. * the effectiveness on the improvement of facial skin quality by objective measurements of skin biomechanical parameters using Cutometer® and skin hydration using Moisturemeter®. * subject's satisfaction and subject's opinion on aesthetic improvement. * the injector's satisfaction on the injection quality. * the safety using clinical evaluation of the Injection Site Reactions (ISR).

Conditions

• Aesthetic Dermatology

Interventions

Type	Name	Description
DEVICE	Dermal Filler Device	Injection of the device by investigators according to the IFU

Timeline

• Start date: 2023-12-08
• Primary completion: 2024-08-20
• Completion: 2024-08-20
• First posted: 2023-11-21
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

1 site across 1 country: Switzerland