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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
Lead sponsor
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
—
Enrollment
24
estimated
Study population
Healthy volunteers
Key I/E criterion
•Female
Primary endpoints
•Global Fine Lines•Overall Hyperpigmentation•Skin Tone Evenness
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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).
11. 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.
1. 1. 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.
2. 2. 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.
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.
11. 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.
12. Subjects with scarring in the treatment areas. Subjects with a history of keloids will be excluded.
13. Subjects who spray tanned or used sunless tanners in the treatment areas 4 weeks prior to study treatment.
14. 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.
15. Inability to ambulate following the procedure.
16. History of lidocaine and/or tetracaine sensitivity deemed by the investigator to preclude subject from enrolling into study.
17. Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study.
18. Subjects planning any cosmetic procedure to the treatment area during the study period, other than the treatment that will be performed by the investigator.
19. Use of topical steroids, retinoids/retinols, or vitamin C to the face within the previous 2-weeks of screening.
20. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Patient-reported / QoL
2 endpointsPhysical Global Aesthetic Improvement Scale
Time frame:Day 30 and Day 60
PGI, change
categorical status, improvement
Subject Global Aesthetic Improvement Scale
Time frame:Day 30 and Day 60
PGI, change
categorical status, improvement
Other clinical outcomes
7 endpointsGlobal Fine Lines
Time frame:Screening, Day 30, Day 60
descriptive, improvement
Overall Hyperpigmentation
Time frame:Screening, Day 30, Day 60
descriptive, improvement
Skin Tone Evenness
Time frame:Screening, Day 30, Day 60
descriptive, improvement
Skin Firmness
Time frame:Screening, Day 30, Day 60
descriptive, improvement
Skin Radiance/ Brightness
Time frame:Screening, Day 30, Day 60
change from baseline, improvement
Skin Texture Smoothness
Time frame:Screening, Day 30, Day 60
descriptive, improvement
Global Wrinkles
Time frame:Screening, Day 30, Day 60
descriptive, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.