Prospective, spontaneous, open-label pre-market clinical trial with a single injection session; monitoring visits at baseline and 60 days post-treatment.
Two visits will be conducted during the study:
* a baseline visit, during which the first injection will be administered * a final visit, 60 days after the baseline visit, for final assessment
The experimental design involves injection into the deep subdermal layer with the investigational product during the baseline visit, following the study procedure assessments.
Typically, 0.9 ml per side of the face is administered using the retrograde fan technique.
The study duration is 2 months; safety evaluation will be conducted using non-invasive instrumental assessments such as skin hydration (corneometry) and medical device safety and subjective assessments (see below).
Both sexes;
Caucasian race;
Aged between 35 and 65 years;
Non-smokers;
Pregnancy (applicable only to non-menopausal female subjects);
Breastfeeding (applicable only to non-menopausal female subjects);
Smokers;
Alcohol abuse and/or drug use;
Single group
Treatment with experimental device
DeviceInjection of recombinant collagen-based product
Safety based on number of adverse events from the enrollment for the 60days till the second visit and study closing.
The AE will be monitored in terms on number by severity compared to standard
Efficacy based on skin hydration measured with corneometer and assessment with WSRS
Wrinkle severity rate scale used to check efficacy
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303 Pharma s.r.l.
Lead sponsor
Nextrasearch S.r.l.s.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
