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Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel
Sponsor: Biovico Sp. z o.o.
Summary
The aim of this study is to evaluate the efficacy and safety of intradermal injections of the medical device - hyaluronic acid with the addition of lecithin - in a population of participants with thin, dry, and sagging facial skin.
Official title: Assessment of the Safety and Efficacy of the DensiStim Medical Device, an Injectable Liposomal Gel, in Adult Participants
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-05-23
Completion Date
2026-04-23
Last Updated
2025-05-30
Healthy Volunteers
No
Interventions
Injection of the investigational product via needle
A hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via needle
Injection of the investigational product via cannula
A hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via cannula
Clinical assessment
Clinical assessment of facial skin condition
Ultrasound measurement
Ultrasound measurement of facial skin thickness
Multispectral imaging
Multispectral imaging and analysis of facial skin
Locations (1)
Dr Agnieszka Sirocka - Medycyna Estetyczna
Kowale, Poland