Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel (DensiStim)

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging; Facial Skin Laxity; Facial Wrinkles; Skin Wrinkling
• Intervention / Treatment: Device: Injection of the investigational product via needle; Procedure: Clinical assessment; Procedure: Ultrasound measurement; Procedure: Multispectral imaging; Device: Injection of the investigational product via cannula

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kowale, Poland, 80-180
    • Dr Agnieszka Sirocka - Medycyna Estetyczna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: needle group; product administration using a needle	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; 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
Experimental: cannula group; product administration using a 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of participants satisfied with the results of the injections		1 months and 2 months post-treatment
Post-injection sensation scores, assessed by participants using the Numeric Rating Scale Questionnaire	NRS scale 0-10, where 0 indicates no pain/stinging/burning/sensation of pressure, and 10 indicates the worst imaginable pain/stinging/burning/sensation of pressure	after first injection, after second injection, after third injection
Incidence of adverse events by event type		From enrollment to 2 months after the last injection
Percentage of participants who discontinued treatment due to adverse events		From enrollment to 2 months after the last injection
Change in aesthetic improvement and psychological well-being scores, assessed by participants	Change in aesthetic improvement scores (skin hydration, elasticity, firmness, visibility of deep and fine wrinkles, skin tone, and tone evenness) were assessed on a 0-10 scale, where 0 represented the worst score for a given parameter and 10 represented the best score for that parameter; psychological well-being scores were assessed on a 4-point ordinal scale ('very unsatisfactory', 'rather unsatisfactory', 'rather satisfactory', 'very satisfactory').	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	Change in aesthetic improvement scores (skin hydration, elasticity, firmness, visibility of deep and fine wrinkles, skin tone, and tone evenness) were assessed on a 0-10 scale, where 0 represented the worst score for a given parameter and 10 represented the best score for that parameter.	baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment

Collaborators and Investigators

• Sponsor: Biovico Sp. z o.o.
• Investigators: Principal Investigator: Agnieszka Sirocka

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2025
• Primary Completion (Actual): November 7, 2025
• Study Completion (Actual): November 7, 2025

Study Registration Dates

• First Submitted: May 14, 2025
• First Submitted That Met QC Criteria: May 21, 2025
• First Posted (Actual): May 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hyaluronic acid; dry skin; intradermal injection; skin rejuvenation; skin biostimulation; facial skin rejuvenation; thin skin
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: DensiStim

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No