Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTaumedika s.r.l.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
all sexes
caucasic
18 to 70 years
non smoker
Disqualifiers
Pregnancy
milking
smoker
alcohol or drugs abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Karisma
DeviceIntradermal injection
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Face treatmentExperimental treatment 1 intervention
Group B: Lips treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety: no adverse events
test the safety of the device evaluating any potential adverse event
Time frame
16 weeks2
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale
Time frame
16 weeks3
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS)
Time frame
16 weeks4
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface evaluating the face volume
Time frame
16 weeksSecondary outcomes
1
Duration of the efficacy
measure the duration of the treatment
Time frame
16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Taumedika s.r.l.
Lead sponsor
Nextrasearch S.r.l.s.
Collaborator
Source ClinicalTrials.gov