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| Name | Class |
|---|---|
| Opera CRO, a TIGERMED Group Company | OTHER |
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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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plenhyage® thin | Experimental | Plenhyage® thin for the treatment of mild wrinkles; |
|
| Plenhyage® medium | Experimental | Plenhyage® medium for the treatment of moderate wrinkles; |
|
| Plenhyage® strong | Experimental | Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plenhyage® thin | Device | 0.75% |
| |
| Plenhyage® medium |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCM Dr. Rosu | Timișoara | Timiș County | 300425 | Romania |
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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
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| Device |
2% |
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| Plenhyage® strong | Device | 2.5% |
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| 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. | 12 weeks |
| Treatment satisfaction | 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; | 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; | 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; | 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. | 12 weeks |