Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel

NCT06997380 | Completed

• 1 other identifier: DensiStim
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Aging; Skin Wrinkling; Facial Wrinkles; Facial Skin Laxity

Keywords

hyaluronic acid; skin biostimulation; intradermal injection; facial skin rejuvenation; dry skin; thin skin; skin rejuvenation

Outcome Measures

Primary Outcomes (1)

• Change in facial skin thickness

  Change from baseline in facial skin thickness following three intradermal administrations of the DensiStim product, based on ultrasound measurements.

  No later than 8 weeks after the last injection

Secondary Outcomes (9)

• Change in facial skin thickness based on ultrasound measurements, comparison between visits

  baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment

• Change in facial skin thickness based on ultrasound measurements, comparison between study arms

  baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment

• Change in facial skin parameters based on multispectral skin analysis

  baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment

• Change in aesthetic improvement and psychological well-being scores, assessed by participants

  baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment

• Change in aesthetic improvement scores, assessed by the Investigator

  baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment

Study Arms (2)

needle group

EXPERIMENTAL

product administration using a needle

Device: Injection of the investigational product via needle; Procedure: Clinical assessment; Procedure: Ultrasound measurement; Procedure: Multispectral imaging

cannula group

EXPERIMENTAL

product administration using a cannula

Device: Injection of the investigational product via cannula; Procedure: Clinical assessment; Procedure: Ultrasound measurement; Procedure: Multispectral imaging

Interventions

Injection of the investigational product via needle DEVICE

A hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via needle

needle group

Injection of the investigational product via cannula DEVICE

A hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via cannula

cannula group

Clinical assessment PROCEDURE

Clinical assessment of facial skin condition

cannula group; needle group

Ultrasound measurement PROCEDURE

Ultrasound measurement of facial skin thickness

cannula group; needle group

Multispectral imaging PROCEDURE

Multispectral imaging and analysis of facial skin

cannula group; needle group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex;
• Age over 18 years;
• Caucasian race;
• Thin, dry, and sagging facial skin;
• Signing an informed consent form;
• Commitment to refrain from undergoing facial therapies that may affect skin condition;
• Negative pregnancy test result and commitment to use a contraceptve method;

You may not qualify if:

• Scars, birthmarks, or tattoos on the face that could interfere with the assessment of skin condition;
• Presence of open wounds, ulcers, active infections, or other significant skin damage at the planned injection site;
• Receipt of intradermal facial injections with native hyaluronic acid, platelet-rich plasma, or other injectable therapies within 6 months prior to study initiation;
• Receipt of intradermal facial injections with slowly absorbable or non-absorbable filler products within 12 months prior to study initiation;
• Known hypersensitivity to any component of the investigational product;
• Dermatitis or dermatological disease of inflammatory and/or infectious nature at the planned injection site;
• History of cancer, autoimmune disease, or immunodeficiency;
• Use of medications affecting blood coagulation;
• Use of topical antihistamines, corticosteroids, or retinoids on the face within 4 weeks prior to the study;
• Pregnancy or breastfeeding;
• Participation or planned participation in other clinical trials;

Sponsors & Collaborators

• Biovico Sp. z o.o.: lead

Study Sites (1)

Dr Agnieszka Sirocka - Medycyna Estetyczna

Kowale, 80-180, Poland

Location

Study Officials

• Agnieszka Sirocka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 30, 2025
• Study Start: May 23, 2025
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

PL (1)