Mastelli Srl

This is a post-market, monocentric, interventional, single-arm, confirmative clinical investigation to evaluate the performance and the safety of PN+HA (NEWEST) for the improvement of skin hydration.
Each Subject, after signing the Informed Consent Form (ICF), will enter into a screening/baseline phase during which the baseline tests will be conducted. The Subject can be treated immediately after signing the ICF.
For each Subject, 5 visits will be planned during which several assessments will be performed as described in the Flowchart:
* V0 (Screening/baseline): Day 0, when the first IP injection will be performed;
* V1: 2 weeks ± 7 days from V0, when the second IP injection will be performed;
* V2: 2 weeks ± 7 days from V1, when the third IP injection will be performed (End Of Treatment/EOT);
* V3: maximum 4 months from V0 and 2 months after the last IP injection (V2);
* V4: maximum 6 months form V0 and 4 months after the last IP injection (V2).
At V0, the Investigator will collect demographic data (e.g., gender, age, skin phototype according to Fitzpatrick's classification), medical history (e.g., history of autoimmune disease, diabetes, etc.), drug allergy history of the enrolled Subject.
At V0, V1, and V2 according to the instructions for use (IFU), the enrolled Subjects will be treated with PN+HA in maximum 2 areas of the face, or 1 area of the face plus neck/décolleté/back of the hands, making sure that at least 10 areas of face, neck, décolleté and back of the hands will be reached.
Local anesthetics containing lidocaine may be used in order to guarantee the necessary comfort to the Subject.
Performance will be evaluated by the Investigator using the Global Aesthetic Improvement Scale (GAIS) at each visit. The GAIS will be independently completed by the Investigator and the Subject. Photographs with a 2D camera will be taken at each visit. Skin hydration will be assessed by using the MoistureMeterEpiD (at least three measurements will be obtained per each area treated) at each visit.
Skin elasticity will be evaluated using the ElastiMeter (at least three measurements will be obtained per each area treated) at each visit.
Skin turgor will be assessed by the Investigator using a 5-Likert scale at each visit.
At V0, V1 and V2 after injection, the Investigator will record Subjects' pain intensity using the Numerical Rating Scale (NRS).
Subject satisfaction with treatment will be evaluated with a 5-point Likert Scale at V3 and EOS visit (V4).
Safety will include evaluation of possible cutaneous reactions at each visit. Adverse events, concomitant medications, and device deficiencies will be monitored during the entire duration of the study.

This is a prospective, open label, controlled, exploratory clinical investigation aimed to evaluate the clinical benefit and safety of Tropho Tend in the conservative management of painful Rotator Cuff Tendinopathy (RCT).
All subjects will be involved in the clinical investigation for 4 months for a total of 5 visits (T0= basal visit, T1, T2, T3, T4).
The control group will be represented by patients diagnosed with rotator cuff tendinopathy treated with rehabilitation physiotherapy (standard of care).
The therapy group will be represented by patients diagnosed with rotator cuff tendinopathy treated with rehabilitation physiotherapy + TrophoTend perilesional injection (TrophoTend will be added on to current standard of care).
All the screened patients at the baseline visit (T0), after checking the inclusion/exclusion criteria, will be prospectively included in the clinical investigation, in a 1:1 randomization. Patients will be randomly assigned to the "control group" (N=30pts), receiving rehabilitation physiotherapy (standard of care), or to the "therapy group" (N=30 pts), receiving Tropho Tend as a add on therapy to the rehabilitation physiotherapy.
Total duration of Clinical Investigation will be 12 months: 2-4 months for patients screening and enrolment; 1 month of therapy administration (3 perilesional injections 2 weeks apart); 3 months of follow-up; 2-4 months for data analysis and final report/paper elaboration.
At the baseline visit (T0), an ultrasound evaluation (EUS) has to be performed to assess tendon condition. If an EUS evaluation performed within one month from T0 is available, this will be considered acceptable. This first evaluation has to be compared with another EUS performed at the final visit to obtain a qualitative description of the ultrasound appearance of the tendon after the treatment.
Patients' enrolment will take 2-4 months. Tropho Tend will be administrated at T0 (basal visit) at T1 (2 weeks) and at T2 (4 weeks) for a total duration of treatment of 1 month.
Follow-up will be performed at T3 (8 weeks) and T4 (12 weeks= 3 months). End of the clinical investigation will be considered the last visit for the last enrolled patient.
A 40% reduction in mean VAS scores between the "Tropho Tend therapy group" and the "control group" is considered as reflecting meaningful clinical improvement for the patient.
At the final visit, the patient has to rate his/her satisfaction with the treatment using a 5-points Likert scale, where 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=highly satisfied.

This is a post-market, monocentric, interventional, single-arm, confirmative clinical investigation to evaluate the performance and the safety of PN20 (PLINEST) for the improvement of skin hydration.
Each Subject, after signing the Informed Consent Form (ICF), will enter into a screening/baseline phase during which the baseline tests will be conducted. The Subject can be treated immediately after signing the ICF.
For each Subject, 5 visits will be planned during which several assessments will be performed as described in the Flowchart:
* V0 (Screening/baseline): Day 0, when the first IP injection will be performed;
* V1: 2 weeks ± 7 days from V0, when the second IP injection will be performed;
* V2: 2 weeks ± 7 days from V1, when the third IP injection will be performed (End Of Treatment/EOT);
* V3: maximum 4 months from V0 and 2 months after the last IP injection (V2);
* V4: maximum 6 months form V0 and 4 months after the last IP injection (V2).
At V0, the Investigator will collect demographic data (e.g., gender, age, skin phototype according to Fitzpatrick's classification), medical history (e.g., history of autoimmune disease, diabetes, etc.), drug allergy history of the enrolled Subject.
At V0, V1, and V2 according to the instructions for use (IFU), the enrolled Subjects will be treated with PN20 in maximum 2 areas of the face, or 1 area of the face plus neck/décolleté, making sure that at least 14 areas for face, neck and décolleté will be reached.
Local anesthetics containing lidocaine may be used in order to guarantee the necessary comfort to the Subject.
Performance will be evaluated by the Investigator using the Global Aesthetic Improvement Scale (GAIS) at each visit. The GAIS will be independently completed by the Investigator and the Subject. Photographs with a 2D camera will be taken at each visit. Skin hydration will be assessed by using the MoistureMeterEpiD (at least three measurements will be obtained per each area treated) at each visit.
Skin elasticity will be evaluated using the ElastiMeter (at least three measurements will be obtained per each area treated) at each visit.
Skin turgor will be assessed by the Investigator using a 5-Likert scale at each visit.
At V0, V1 and V2 after injection, the Investigator will record Subjects' pain intensity using the Numerical Rating Scale (NRS).
Subject satisfaction with treatment will be evaluated with a 5-point Likert Scale at V3 and EOS visit (V4).
Safety will include evaluation of possible cutaneous reactions at each visit. Adverse events, concomitant medications, and device deficiencies will be monitored during the entire duration of the study.