Skin AgingDensiStimNCT06997380
Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel
A study testing Injection of the investigational product via needle, Injection of the investigational product via cannula and Clinical assessment in people with Skin Aging and Skin Wrinkling, run by Biovico Sp. z o.o. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Skin Aging, Skin Wrinkling, Facial Skin Laxity
- What is being tested?
- Injection of the investigational product via needle, Injection of the investigational product via cannula and Clinical assessment
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- 23 May 2025to 7 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin Aging, Skin Wrinkling, Facial Skin Laxity, Facial Wrinkles
- Being tested
- Injection of the investigational product via needle, Injection of the investigational product via cannula, Clinical assessment, Ultrasound measurement, Multispectral imaging
- Keywords
- hyaluronic acid, skin biostimulation, intradermal injection, facial skin rejuvenation, dry skin, thin skin, skin rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of the investigational product via needleDevice
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 cannulaDevice
A hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via cannula
Clinical assessmentProcedure or surgery
Clinical assessment of facial skin condition
Ultrasound measurementProcedure or surgery
Ultrasound measurement of facial skin thickness
Multispectral imagingProcedure or surgery
Multispectral imaging and analysis of facial skin
| Study group | Role | What they receive |
|---|---|---|
| needle group | Experimental | product administration using a needle Receives: 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 Receives: Device: Injection of the investigational product via cannula; Procedure: Clinical assessment; Procedure: Ultrasound measurement; Procedure: Multispectral imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in facial skin thickness
Change from baseline in facial skin thickness following three intradermal administrations of the DensiStim product, based on ultrasound measurements.
Measured: No later than 8 weeks after the last injection
Secondary outcomes (9)
Change in facial skin thickness based on ultrasound measurements, comparison between visits
Measured: 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
Measured: 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
Measured: 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
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').
Measured: 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.
Measured: 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
Measured: 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
Measured: after first injection, after second injection, after third injection
Incidence of adverse events by event type
Measured: From enrollment to 2 months after the last injection
Percentage of participants who discontinued treatment due to adverse events
Measured: From enrollment to 2 months after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start23 May 2025
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biovico Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Agnieszka Sirocka, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997380
- Sponsor's protocol ID
- DensiStim
- Acronym
- DensiStim
- Status last verified
- Apr 2026
- First submitted
- 14 May 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Efficacy of the DensiStim Medical Device, an Injectable Liposomal Gel, in Adult Participants
- ClinicalTrials.gov ID
- NCT06997380
- Acronym / sponsor ID
- DensiStim / DensiStim
- Conditions
- Skin Aging, Skin Wrinkling, Facial Skin Laxity, Facial Wrinkles
- Keywords
- hyaluronic acid, skin biostimulation, intradermal injection, facial skin rejuvenation, dry skin, thin skin, skin rejuvenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Biovico Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| needle group | Experimental | Device: Injection of the investigational product via needle, Procedure: Clinical assessment, Procedure: Ultrasound measurement, Procedure: Multispectral imagingproduct administration using a needle |
| cannula group | Experimental | Device: Injection of the investigational product via cannula, Procedure: Clinical assessment, Procedure: Ultrasound measurement, Procedure: Multispectral imagingproduct administration using a cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female sex;
- Age over 18 years;
- Caucasian race;
- Thin, dry, and sagging facial skin;
- Signing an informed consent form;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of the investigational product via needleA hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via needle | Device | needle group |
| Injection of the investigational product via cannulaA hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via cannula | Device | cannula group |
| Clinical assessmentClinical assessment of facial skin condition | Procedure or surgery | cannula group, needle group |
| Ultrasound measurementUltrasound measurement of facial skin thickness | Procedure or surgery | cannula group, needle group |
| Multispectral imagingMultispectral imaging and analysis of facial skin | Procedure or surgery | cannula group, needle group |
Primary outcome
Change in facial skin thickness
Time frame: 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.
9 secondary outcomes
Change in facial skin thickness based on ultrasound measurements, comparison between visits
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 months and 2 months post-treatment
Post-injection sensation scores, assessed by participants using the Numeric Rating Scale Questionnaire
Time frame: after first injection, after second injection, after third injection
Incidence of adverse events by event type
Time frame: From enrollment to 2 months after the last injection
Percentage of participants who discontinued treatment due to adverse events
Time frame: From enrollment to 2 months after the last injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Sirocka principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of the investigational product via needle, Injection of the investigational product via cannula and Clinical assessment in people with Skin Aging and Skin Wrinkling, run by Biovico Sp. z o.o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in facial skin thickness (time frame: No later than 8 weeks after the last injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.