NCT06997380

Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel

Assessment of the Safety and Efficacy of the DensiStim Medical Device, an Injectable Liposomal Gel, in Adult Participants

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Biovico Sp. z o.o. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 36 participants are planned to be enrolled in the study (18 in each group: Group 1 - product administration using a needle; Group 2 - product administration using a cannula). The primary endpoint will be the change in facial skin thickness resulting from three administrations of the DensiStim product, assessed no later than 8 weeks after the last procedure, based on ultrasound (US) measurements. Ultrasound measurements will also be compared between visits and between study arms. Changes in aesthetic improvement will be assessed by both the participant and the Investigator. The safety of the investigational medical device will also be evaluated.

Conditions

• Skin Aging
• Skin Wrinkling
• Facial Skin Laxity
• Facial Wrinkles

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-23
• Primary completion: 2025-12-23
• Completion: 2026-04-23
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: Poland