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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| needle group | Experimental | product administration using a needle |
|
| cannula group | Experimental | product administration using a cannula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of the investigational product via needle | Device | A hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via needle |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Sirocka | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Agnieszka Sirocka - Medycyna Estetyczna | Kowale | 80-180 | Poland |
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| Injection of the investigational product via cannula | Device | A hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via cannula |
|
| Clinical assessment | Procedure | Clinical assessment of facial skin condition |
|
| Ultrasound measurement | Procedure | Ultrasound measurement of facial skin thickness |
|
| Multispectral imaging | Procedure | Multispectral imaging and analysis of facial skin |
|
| 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 | 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 |
| 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 |