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

NCT07221461 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: Skinvive GLP1 agonist
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkle

Keywords

skin laxity; fine lines; dull skin; uneven skin tone

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (2)

• Physical Global Aesthetic Improvement Scale

  Day 30 and Day 60

• Subject Global Aesthetic Improvement Scale

  Day 30 and Day 60

Study Arms (2)

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.

Device: Skinvive

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.

Device: Skinvive

Interventions

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.

GLP1 Patients; NON GLP1 Patients

Eligibility Criteria

• Age: 25 Years - 50 Years
• Gender Eligibility Details: Female at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• \. Acceptable methods of birth control are: oral contraceptive pill, injections, implants, patches, vaginal rings, intrauterine device/coil, double-barrier methods (e.g., sponge, spermicide, or condoms). Abstinence and/or vasectomized partner must agree to a second acceptable method of birth control (double-barrier) should the subject become sexually active.
• \. A female is considered of non-childbearing potential if she is: postmenopausal (no menses for at least 12 months), without a uterus (hysterectomy) and/or both ovaries (oophorectomy), or bilateral tubal ligation.

You may not qualify if:

• 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.
• Current use of immunosuppressive medication.
• Weight change of greater than 10% during the study period.
• Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
• 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.
• 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.
• Any investigational treatment for skin quality of the cheeks during the 12-month period before the study treatment.
• Creams/cosmeceuticals and/or home therapies for the prevention or treatment of skin fine lines, wrinkles, radiance, elasticity, firmness, or smoothness in the treatment area during the 4-week period before study treatment and throughout the course of the study.
• Subjects with scarring in the treatment areas. Subjects with a history of keloids will be excluded.
• Subjects who spray tanned or used sunless tanners in the treatment areas 4 weeks prior to study treatment.
• History of bleeding disorder, concomitant use of anticoagulants, history of connective tissue disease (e.g., lupus, scleroderma), history of Bell's Palsy, epilepsy, smoking, and/or current pregnancy or breastfeeding.
• Inability to ambulate following the procedure.

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

Study Sites (1)

West Dermatology Research Center

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Andrea Pacheco

CONTACT

858-657-1004; apacheco@clderm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects (16 GLP1 and 8 non-GLP1) will receive one treatment with microdroplet hyaluronic acid filler (SKINVIVE™, JUVÉDERM®, Irvine, CA) to the cheeks.

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 28, 2025
• Study Start: November 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: March 2, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

US (1)