Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel

Not Applicable

• Conditions: Skin Aging; Skin Wrinkling; Facial Skin Laxity; Facial Wrinkles

• Registration Number: NCT06997380
• Lead Sponsor: Biovico Sp. z o.o.

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.

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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study Start: 2025-05-23
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-12-23
• Study Completion: 2026-04-23

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in facial skin thickness	No later than 8 weeks after the last injection	Change from baseline in facial skin thickness following three intradermal administrations of the DensiStim product, based on ultrasound measurements.

Secondary Outcome Measures

Name	Time	Method
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
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	after first injection, after second injection, after third injection	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
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

Trial Locations

Locations (1)

Dr Agnieszka Sirocka - Medycyna Estetyczna; 🇵🇱 Kowale, Poland