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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP1 Patients | Active Comparator | 16 participants who have been on a stable dose of GLP-1 agonist medication for at least the last 6 months will receive one treatment with microdroplet hyaluronic acid filler (SKINVIVE™, JUVÉDERM®, Irvine, CA) to the cheeks. |
|
| NON GLP1 Patients | Experimental | 8 participants who are GLP1 naive will receive one treatment with microdroplet hyaluronic acid filler (SKINVIVE™, JUVÉDERM®, Irvine, CA) to the cheeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skinvive | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Fine Lines | Score 0 no fine lines thru 9 numerous, many fine lines | Screening, Day 30, Day 60 |
| Overall Hyperpigmentation | Score 0= no hyperpigmentation thru 9= significant hyperpigmentation | Screening, Day 30, Day 60 |
| Skin Tone Evenness | Score 0= Very even tone thru Score 9= Uneven, discolored appearance (brown and/or red colors) | Screening, Day 30, Day 60 |
| Skin Firmness | Score 0= Firm, tight feeling skin thru Score 9= Loose, lax feeling skin | 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 | 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 | 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 | Screening, Day 30, Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Global Aesthetic Improvement Scale | Assess improvement of Abdominal skin laxity: Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2 | Day 30 and Day 60 |
| Subject Global Aesthetic Improvement Scale |
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Inclusion Criteria:
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).
Participants must maintain a stable weight, defined as no greater than a 10% weight change from screening/baseline and throughout the study.
Participants must have a body mass index (BMI) of 27 or less.
Must be willing to sign a photography release and ICF, and complete the entire course of the study.
Participant must agree to maintaining the same skincare routine they are currently using throughout the study period.
Subjects in good general health based on investigator's judgment and medical history.
Negative urine pregnancy test result at the time of study entry (if applicable).
Females of childbearing potential must be willing to use an acceptable method of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
Exclusion Criteria:
Female at birth
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pacheco | Contact | 858-657-1004 | apacheco@clderm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology Research Center | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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All subjects (16 GLP1 and 8 non-GLP1) will receive one treatment with microdroplet hyaluronic acid filler (SKINVIVE™, JUVÉDERM®, Irvine, CA) to the cheeks.
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Assess improvement of Abdominal skin laxity:
Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2
| Day 30 and Day 60 |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |