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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
University of Minnesota
Minneapolis, Minnesota, United States
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.
Time frame: Week 32
Change in Global Aesthetic Improvement Scale
This is a 7 point scale to assess degree of improvement of facial skin after treatment.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Immediately after 1st, 2nd and 3rd treatments
Wrinkle assessment
Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles.
Time frame: Week 32
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