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ENROLLING BY INVITATION
NCT06997380
NA

Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel

Sponsor: Biovico Sp. z o.o.

View on ClinicalTrials.gov

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

DEVICE

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

DEVICE

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

PROCEDURE

Clinical assessment

Clinical assessment of facial skin condition

PROCEDURE

Ultrasound measurement

Ultrasound measurement of facial skin thickness

PROCEDURE

Multispectral imaging

Multispectral imaging and analysis of facial skin

Locations (1)

Dr Agnieszka Sirocka - Medycyna Estetyczna

Kowale, Poland