The Research Question of the present study is the following: in a population of men and women affected by face wrinkles and skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks, will Plenhyage® significantly decrease the appearance of treated areas, results observed after 8 and 12 weeks?
Open, non-comparative, interventional, multicenter study with the total number of screened subjects of 66 (60 evaluable subjects +6 potential screening failure): * 20 patients will be administered Plenhyage® thin for the treatment of mild wrinkles; * 20 patients will be administered Plenhyage® medium for the treatment of moderate wrinkles; * 20 patients will be administered Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks;
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
SCM Dr. Rosu
Timișoara, Timiș County, Romania
Wrinkle Severity Rating Scale score evaaluated by the Investigator
The WSRS score performed by Investigator have been chosen as a primary efficacy outcome to measure the performance of the Plenhyage® thin and medium. The scale has 5 grades: 1 absent, 2 mild, 3 moderate, 4 severe, 5 extreme, where 1 absent represents no visible folds and 5 extreme represent extreme deep and long folds.
Time frame: 12 weeks
Aesthetic Numeric Scale evaluated by the Investigator
The ANA score will be evaluated on a point scale from 0 to 10 where: 0 - Insufficient 1. \- Unsatisfied 2. \- Poor 3. \- Sufficient 4. \- Neutral 5. \- Agreed 6. \- Satisfied 7. \- As requested 8. \- Perfect 9. \- Harmonic 10. \- Highly satisfied The best score for ANA score is 10 highly satisfied and the worst outcome is 0 insufficient
Time frame: 12 weeks
WSRS score evaluated by the subject
The WSRS score performed by subject has been chosen as a secondary efficacy outcome to measure the performance of the Plenhyage® thin and medium. The scale has 5 grades: 1 absent, 2 mild, 3 moderate, 4 severe, 5 extreme, where 1 absent represents no visible folds and 5 extreme represent extreme deep and long folds.
Time frame: 12 weeks
Global Aesthetic Improvement Scale
Subjects will evaluate their skin appearance change compared to before the treatment, as follows: Very Much Improved (1) = Optimal cosmetic result; Much Improved (2) = Market improvement in appearance but not completely optimal. A touch-up would slightly improve the result; Improved (3) = Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated; No Change (4) = The appearance is essentially the same as the original condition; Worse (5) = The appearance is worse than the original condition.
Time frame: 12 weeks
Treatment satisfaction
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Treatment satisfaction will be assessed by the subject at 4, 8 and 12 weeks using a 4-point scale: very satisfied, satisfied, moderate and not satisfied;
Time frame: 12 weeks
Investigator Global Assessment of Performance
Investigator Global Assessment of Performance (IGAP) Investigator will make photographs at every visit (1, 2, 3, 4 and 5) of the area treated in order to evaluate the performance of the treatment at visit 5 using a 4-point scale: 1= very good performance, 2 = good performance, 3 = moderate performance and 4 = poor performance;
Time frame: 12 weeks
Investigator Global Assessment of Safety
Investigator Global Assessment of Safety (IGAS) will be reported using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated by the Investigator at Final visit (12 weeks), only;
Time frame: 12 weeks
Patient Global Assessment of Safety
Patient Global Assessment of Safety (PGAS) will be reported by the subject at the last visit using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. PGAS will be evaluated by the patient at Final visit (12 weeks), only.
Time frame: 12 weeks