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

Biovico Sp. z o.o.

Status: Invitation-only

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06997380

DensiStim

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

needle group

Experimental group

Description:

product administration using a needle

Treatment:

Procedure: Multispectral imaging

Procedure: Ultrasound measurement

Device: Injection of the investigational product via needle

Procedure: Clinical assessment

cannula group

Experimental group

Description:

product administration using a cannula

Treatment:

Procedure: Multispectral imaging

Procedure: Ultrasound measurement

Device: Injection of the investigational product via cannula

Procedure: Clinical assessment