Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Karisma.
- Who it may be relevant to
- Registry conditions: Wrinkle, Scar, Laxity; Skin. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
"Clinical and Instrumental Evaluation of the Safety and Bio-revitalizing Effect on the Face of the Medical Device 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'"
Overview
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
Detailed description
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.
Interventions
- Device Karisma
Intradermal injection
Primary outcome measures
- Safety: no adverse events [Time frame: 16 weeks]
- Efficacy: change of wrinkles and scars [Time frame: 16 weeks]
- Efficacy: change of wrinkles and scars [Time frame: 16 weeks]
- Efficacy: change of wrinkles and scars [Time frame: 16 weeks]
- Efficacy: change of wrinkles and scars [Time frame: 16 weeks]
Secondary outcome measures (1)
- Duration of the efficacy [Time frame: 16 weeks]
Eligibility criteria
Inclusion criteria
- all sexes
- caucasic
- 18 to 70 years
- non smoker
Exclusion criteria
- Pregnancy
- milking
- smoker
- alcohol or drugs abuse
- change of BMI during the study
- previous facial surgery, implants, permanent treatments
- sensitivity to the product
- dermatological difficult frame
- health weakness
- treated with anticoagulants, antihistaminics, corticosteroids, antidepressants and other drugs impacting on the results
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Ospedale Tor Vergata — Roma
Identifiers
NCT: NCT06336044 · Taufiller/22