Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel
NCT ID: NCT06997380
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
36 participants
INTERVENTIONAL
2025-05-23
2026-04-23
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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needle group
product administration using a needle
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
Clinical assessment
Clinical assessment of facial skin condition
Ultrasound measurement
Ultrasound measurement of facial skin thickness
Multispectral imaging
Multispectral imaging and analysis of facial skin
cannula group
product administration using a cannula
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
Clinical assessment
Clinical assessment of facial skin condition
Ultrasound measurement
Ultrasound measurement of facial skin thickness
Multispectral imaging
Multispectral imaging and analysis of facial skin
Interventions
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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
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
Clinical assessment
Clinical assessment of facial skin condition
Ultrasound measurement
Ultrasound measurement of facial skin thickness
Multispectral imaging
Multispectral imaging and analysis of facial skin
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
FEMALE
No
Sponsors
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Biovico Sp. z o.o.
INDUSTRY
Responsible Party
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Principal Investigators
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Agnieszka Sirocka
Role: PRINCIPAL_INVESTIGATOR
Locations
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Dr Agnieszka Sirocka - Medycyna Estetyczna
Kowale, , Poland
Countries
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Other Identifiers
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DensiStim
Identifier Type: -
Identifier Source: org_study_id
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