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Assess Impact of Microdroplet Hyaluronic Acid Filler on Skin Quality in Patients on Glucagon-like Peptide-1 Agonists

Prospective, Single Center, Open-label Study Assessing Impact of Microdroplet Hyaluronic Acid Filler on Skin Quality and Biomarkers in Patients on Glucagon-like Peptide-1 Agonists

NCT07221461•Goldman, Butterwick, Fitzpatrick and Groff

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

25 - 50 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Adult women aged 25-50 years.
•2. Fitzpatrick skin types I-VI.
•3. 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.
•4. 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).
•5. Participants must maintain a stable weight, defined as no greater than a 10% weight change from screening/baseline and throughout the study.
•6. Participants must have a body mass index (BMI) of 27 or less.
•7. Must be willing to sign a photography release and ICF, and complete the entire course of the study.
•8. Participant must agree to maintaining the same skincare routine they are currently using throughout the study period.
•9. Subjects in good general health based on investigator's judgment and medical history.
•10. Negative urine pregnancy test result at the time of study entry (if applicable).
+3 more criteria

Exclusion Criteria

•1. 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).
•2. Females who are pregnant, planning a pregnancy, or currently breast feeding during the study.
•3. Any uncontrolled systemic disease.
•4. History of autoimmune connective tissue disease.
•5. Current use of immunosuppressive medication.
•6. Weight change of greater than 10% during the study period.
•7. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
•8. 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.
•9. Mesotherapy; dermal fillers, biostimulator injectables; radiofrequency device treatments; microfocused ultrasound device treatments; laser and light-based device treatments; microneedling; cryolipolysis; high intensity focused electromagnetic energy device treatment; or surgery during the 12-month period before study treatment. Botulinum toxin injections (Botox, Dysport, Xeomin, Daxify, Jeuveau) during the 6-month period before study treatment.
•10. Any investigational treatment for skin quality of the cheeks during the 12-month period before the study treatment.
+10 more criteria

Locations (1)

West Dermatology Research Center

San Diego, California, United States

Key Dates

Start Date

November 1, 2025

Primary Completion Date

January 30, 2026

Completion Date

March 2, 2026

Last Updated

October 28, 2025

Enrollment

ESTIMATED participants

Conditions

Wrinkle

Interventions

Skinvive

DEVICE

Contacts

Andrea Pacheco

CONTACT

858-657-1004 apacheco@clderm.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assess Impact of Microdroplet Hyaluronic Acid Filler on Skin Quality in Patients on Glucagon-like Peptide-1 Agonists

Inclusion Criteria

Exclusion Criteria

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