ClinicalTrials.gg
Not yet recruitingNCT07221461Updated Oct 28, 2025

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

A Phase 2 interventional study of Skinvive in Wrinkle, sponsored by Goldman, Butterwick, Fitzpatrick and Groff. Not yet recruiting at 1 site in United States. Open to female participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-28.

Sponsored by Goldman, Butterwick, Fitzpatrick and Groff · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
25 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Wrinkle

Keywords

  • skin laxity
  • fine lines
  • dull skin
  • uneven skin tone
03

In context

Lead sponsor

Goldman, Butterwick, Fitzpatrick and Groff is the lead sponsor of 41 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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 must be willing to use an acceptable method of 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: (no menses for at least 12 months), without a uterus (hysterectomy) and/or both ovaries (oophorectomy), or bilateral tubal ligation.

Exclusion 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 connective tissue disease.
  5. Current use of 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 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 , 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    GLP1 Patients

    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

  • Experimental
    NON GLP1 Patients

    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

  • DeviceSkinvive

    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.

06

What researchers measure

Primary outcomes

  1. Global Fine Lines

    Score 0 no fine lines thru 9 numerous, many fine lines

    Time frame: Screening, Day 30, Day 60

  2. Overall Hyperpigmentation

    Score 0= no hyperpigmentation thru 9= significant hyperpigmentation

    Time frame: Screening, Day 30, Day 60

  3. Skin Tone Evenness

    Score 0= Very even tone thru Score 9= Uneven, discolored appearance (brown and/or red colors)

    Time frame: Screening, Day 30, Day 60

  4. Skin Firmness

    Score 0= Firm, tight feeling skin thru Score 9= Loose, lax feeling skin

    Time frame: Screening, Day 30, Day 60

  5. Skin Radiance/ Brightness

    Score 0= Very radiant, luminous or glowing appearance thru Score 9= Very dull/ matte and/or sallow skin appearance

    Time frame: Screening, Day 30, Day 60

  6. Skin Texture Smoothness

    Score 0= Very smooth, even-looking skin texture, no roughness thru Score 9= Very rough, pronounced, extensive visible skin roughness

    Time frame: Screening, Day 30, Day 60

  7. 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

    Time frame: Screening, Day 30, Day 60

Secondary outcomes

  1. Physical Global Aesthetic Improvement Scale

    Assess improvement of Abdominal skin laxity: Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2

    Time frame: Day 30 and Day 60

  2. Subject Global Aesthetic Improvement Scale

    Assess improvement of Abdominal skin laxity: Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2

    Time frame: Day 30 and Day 60

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07221461
Lead sponsor
Goldman, Butterwick, Fitzpatrick and Groff
Responsible party
Sponsor
First posted
Oct 28, 2025
Start date
Nov 1, 2025 (estimated)
Primary completion
Jan 30, 2026 (estimated)
Completion
Mar 2, 2026 (estimated)
Last update
Oct 28, 2025

Study contacts

Andrea Pacheco
Contact
apacheco@clderm.com
858-657-1004

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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