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This study will assess the efficacy of Cellular MatrixTM BCT-HA Kit treatment compared to placebo condition on revitalization and skin rejuvenation on the midface. Particular attention will be made to the safety aspects, as well as the histological consequences of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined HA with PRP | Experimental | Hyaluronic acid and PRP combination treatment |
|
| Placebo | Placebo Comparator | saline solution |
|
| PRP | Active Comparator | Platelet rich plasma without hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3) | Device | Injections with platelet-rich plasma and hyaluronic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skin Quality Rating Scale | Skin Quality Rating Scale is a 10 point scales used to assess skin quality, including radiance, smoothness, pigmentation, erythema, and pore size. | Week 32 |
| Change in Global Aesthetic Improvement Scale | This is a 7 point scale to assess degree of improvement of facial skin after treatment. | Week 32 |
| Change in FACE-Q Score | The following eight FACE-Q scales: (1) satisfaction with overall facial appearance (measures patient satisfaction with the overall appearance of their face); (2) satisfaction with decision (measures patient satisfaction with their decision to undergo the procedure;(3) cheekbones; (4) chin; (5) cheeks; (6) lower face; (7) jawline; and (8) nasolabial folds (items 3 through 8 measure overall and area-specific appearance appraisal to evaluate satisfaction with specific facial areas). Higher FACE-Q scores indicate superior satisfaction | Week 32 |
| Physician's Global assessment to measure quality of life | Patient rating of improvement in treated area ranging from 1 to 5, with 5 being worse. | 4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment |
| Visual Analog Score for patients | Visual analog rating of pain associated with treatment administration ranging between 0 and 10, pain scale. | Immediately after 1st, 2nd and 3rd treatments |
| Wrinkle assessment | Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Hordinsky, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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Blinded, randomized control trial
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The participant, investigator, and dermatopathologist (outcomes assessor) will all be blinded to which group the participant belongs too. Given the color difference of the injected solutions, the syringes with the injection material (HA with PRP or saline) will be masked to prevent the patient or investigator from knowing which material they are injecting.
| PRP Only | Other | platelet rich plasma without hyaluronic acid |
|
| Placebo | Other | Neither PRP nor hyaluronic acid |
|
| Week 32 |