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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
A hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via needle
A hyaluronic acid solution (concentration 2.2%) with the addition of lecithin in the form of liposomes (concentration 0.08%) via cannula
Clinical assessment of facial skin condition
Dr Agnieszka Sirocka - Medycyna Estetyczna
Kowale, Poland
Change in facial skin thickness
Change from baseline in facial skin thickness following three intradermal administrations of the DensiStim product, based on ultrasound measurements.
Time frame: No later than 8 weeks after the last injection
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
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Ultrasound measurement of facial skin thickness
Multispectral imaging and analysis of facial skin
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
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