Clinical trial to assess the effect of microdroplet hyaluronic acid filler to the cheek skin (SKINVIVE™, JUVÉDERM®, Irvine, CA) on skin quality in patients undergoing medical weight loss with GLP-1 therapy.
24 patients total (16 GLP1 and 8 non-GLP1) will receive one treatment with microdroplet hyaluronic acid filler (SKINVIVE™, JUVÉDERM®, Irvine, CA) to the cheeks, either at the beginning of the study or at the end. Patients will return for follow up visits at day 30, day 60 and and day 70, where they will undergo standardized 2D photography, VISIA photography and assessments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
16 GLP1 subjects treated with Skinvive to their cheeks for skin quality will be compared to 8 NON-GLP1 subjects treated with Skinvive for skin quality.
West Dermatology Research Center
San Diego, California, United States
Global Fine Lines
Score 0 no fine lines thru 9 numerous, many fine lines
Time frame: Screening, Day 30, Day 60
Overall Hyperpigmentation
Score 0= no hyperpigmentation thru 9= significant hyperpigmentation
Time frame: Screening, Day 30, Day 60
Skin Tone Evenness
Score 0= Very even tone thru Score 9= Uneven, discolored appearance (brown and/or red colors)
Time frame: Screening, Day 30, Day 60
Skin Firmness
Score 0= Firm, tight feeling skin thru Score 9= Loose, lax feeling skin
Time frame: Screening, Day 30, Day 60
Skin Radiance/ Brightness
Score 0= Very radiant, luminous or glowing appearance thru Score 9= Very dull/ matte and/or sallow skin appearance
Time frame: Screening, Day 30, Day 60
Skin Texture Smoothness
Score 0= Very smooth, even-looking skin texture, no roughness thru Score 9= Very rough, pronounced, extensive visible skin roughness
Time frame: Screening, Day 30, Day 60
Global Wrinkles
Score 0= No wrinkles present, no visible deep, wide and long wrinkles, skin looks smooth thru Score 9= Numerous wrinkles, deep, wide and long, densely packed together in the treatment area
Time frame: Screening, Day 30, Day 60
Physical Global Aesthetic Improvement Scale
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Assess improvement of Abdominal skin laxity: Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2
Time frame: Day 30 and Day 60
Subject Global Aesthetic Improvement Scale
Assess improvement of Abdominal skin laxity: Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2
Time frame: Day 30 and Day 60