About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult women aged 25-50 years.
Fitzpatrick skin types I-VI.
Current treatment with a stable dose of GLP-1 agonist medication for at least the last 6 months, for 16 of the enrolled subjects. Remaining 8 subjects should not be taking or have a history of taking a GLP-1 agonist therapy in the last year.
Presence of moderate skin changes (as defined by Modified Griffiths' Scale, with an average score of 4-6) in the following criteria: skin radiance/brightness, skin elasticity, tone evenness, skin firmness, fine lines, global wrinkles, and skin smoothness (tactile and visual).
Disqualifiers
The presence of severe facial skin aging (as defined by Modified Griffiths' Scale, with an average score of 7-9) or minimal facial skin aging (as defined by Modified Griffiths' Scale, with an average score of 0-3).
Females who are pregnant, planning a pregnancy, or currently breast feeding during the study.
Any uncontrolled systemic disease.
History of autoimmune connective tissue disease.
Trial design
Parallel
Treatments tested in this trial
Skinvive
Device16 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.
Treatment groups
Trial outcomes
Primary outcomes
Global Fine Lines
Score 0 no fine lines thru 9 numerous, many fine lines
Overall Hyperpigmentation
Score 0= no hyperpigmentation thru 9= significant hyperpigmentation
Skin Tone Evenness
Score 0= Very even tone thru Score 9= Uneven, discolored appearance (brown and/or red colors)
Skin Firmness
Score 0= Firm, tight feeling skin thru Score 9= Loose, lax feeling skin
Secondary outcomes
Physical Global Aesthetic Improvement Scale
Assess improvement of Abdominal skin laxity: Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2
Subject Global Aesthetic Improvement Scale
Assess improvement of Abdominal skin laxity: Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2
Sponsors and contacts
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