Assess Impact of Microdroplet Hyaluronic Acid Filler on Skin Quality in Patients on Glucagon-like… (NCT07221461) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Assess Impact of Microdroplet Hyaluronic Acid Filler on Skin Quality in Patients on Glucagon-like Peptide-1 Agonists
United States24 participantsStarted 2025-11-01
Plain-language summary
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.
Who can participate
Age range25 Years – 50 Years
SexFEMALE
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Inclusion criteria
âś“. Adult women aged 25-50 years.
âś“. Fitzpatrick skin types I-VI.
âś“. 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.
âś“. 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).
âś“. Participants must maintain a stable weight, defined as no greater than a 10% weight change from screening/baseline and throughout the study.
âś“. Participants must have a body mass index (BMI) of 27 or less.
âś“. Must be willing to sign a photography release and ICF, and complete the entire course of the study.
âś“. Participant must agree to maintaining the same skincare routine they are currently using throughout the study period.
Exclusion criteria
âś•. 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).
âś•. Females who are pregnant, planning a pregnancy, or currently breast feeding during the study.
âś•. History of autoimmune connective tissue disease.
âś•. Current use of immunosuppressive medication.
âś•. Weight change of greater than 10% during the study period.
âś•. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
âś•. Active dermatitis (including but not limited to atopic dermatitis, psoriasis, rosacea, acne, melasma, etc.), active infections, or other skin condition in the proposed treatment area that in the investigator's opinion might interfere with the evaluation of study parameters.