NCT03881189

Efficacy and Tolerance Evaluation of an Injective Treatment for the Area Around the Eyes

Efficacy and Tolerance Evaluation of an Intradermal Injective Treatment for the Area Around the Eyes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Derming SRL · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Efficacy and tolerance evaluation of an intradermal injective HA and aminoacids based treatment for the area around the eyes

Detailed description

Primary end point of this study was to evaluate clinically and by non-invasive instrumental measurements the aesthetic performance on the area around the eyes of the"SUNEKOS® 200" injective treatment. Precisely three micro-injection sessions with an interval of 15 days were performed by a specialized dermatologist using periosteal and subepidermal injection techniques, on the area around the eyes of female volunteers with dark circles. An additional aim of this study is to evaluate the product tolerance by both the investigator and volunteers.

Conditions

• Under-eyes Dark Circles

Interventions

Type	Name	Description
DEVICE	SUNEKOS® 200	The intradermal injection procedure was performed bilaterally, on the area around the eyes including the eyelids, using periosteal and subepidermal injection techniques. This injective procedure consists of micro-wheals of 0.2 ml just above the periosteum and micro-wheals of 0.1 ml very superficially, just under epidermis.

Timeline

• Start date: 2018-11-28
• Primary completion: 2019-03-12
• Completion: 2019-03-12
• First posted: 2019-03-19
• Last updated: 2019-03-21

Locations

1 site across 1 country: Italy