Skin Aging, Skin Wrinkling, Facial Skin Laxity, Facial Wrinkles
Conditions
Keywords
hyaluronic acid, skin biostimulation, intradermal injection, facial skin rejuvenation, dry skin, thin skin, skin rejuvenation
Brief 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.
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.
Interventions
DEVICEInjection 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
DEVICEInjection 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
PROCEDUREClinical assessment
Clinical assessment of facial skin condition
PROCEDUREUltrasound measurement
Ultrasound measurement of facial skin thickness
PROCEDUREMultispectral imaging
Multispectral imaging and analysis of facial skin
Sponsors
Biovico Sp. z o.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in facial skin thickness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in facial skin thickness based on ultrasound measurements, comparison between study arms | 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 | 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 | 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 visits | baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment | — |
| Post-injection sensation scores, assessed by participants using the Numeric Rating Scale Questionnaire | after first injection, after second injection, after third injection | 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 |
| 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 | — |
| Percentage of participants satisfied with the results of the injections | 1 months and 2 months post-treatment | — |
Countries
Poland
Outcome results
None listed