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| Name | Class |
|---|---|
| Nextrasearch S.r.l.s. | OTHER |
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Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events
The patients chosen with facial laxity characteristics, at the first visit will be assessed and will receive the treatment (microinjections) in the cheekbone area, over the lips and in the marionette lines. After 4 weeks the first visit will assess the change of the tissutal structure with non invasive measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face treatment | Experimental | Patients treated for face needs with Karisma micro injections |
|
| Lips treatment | Experimental | Patients treated for face needs with Karisma microinjections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Karisma | Device | Intradermal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: no adverse events | test the safety of the device evaluating any potential adverse event | 16 weeks |
| Efficacy: change of wrinkles and scars | test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale | 16 weeks |
| Efficacy: change of wrinkles and scars | test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS) | 16 weeks |
| Efficacy: change of wrinkles and scars | test the efficacy of the device measuring the skin surface evaluating the face volume | 16 weeks |
| Efficacy: change of wrinkles and scars | test the efficacy of the device measuring the skin surface with skin hydratation measurement | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the efficacy | measure the duration of the treatment | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Campione, Professor | Contact | +393382445642 | elena.campione@uniroma2.it | |
| Adolfo Gasparetto, MD | Contact | +393356641965 | adolfogasparetto@nextrasearch.it |
| Name | Affiliation | Role |
|---|---|---|
| Adolfo Gasparetto, MD | Nextrasearch S.r.l.s. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Tor Vergata | Recruiting | Roma | 00133 | Italy |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
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20 patients for face and 20 for lips will undergo skin characterists measurments at time 0 at +4weeks and at +16 weeks
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| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |