Hyaluronic Acid Filler for Wrinkles

Overseen By Andrea Pacheco

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Must be taking: GLP-1 agonists

Must not be taking: Immunosuppressives, Anticoagulants, Topical steroids, others

Disqualifiers: Severe skin aging, Autoimmune disease, Active dermatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how microdroplet hyaluronic acid filler, an injectable treatment, affects skin quality, particularly in individuals undergoing medical weight loss with GLP-1 therapy. The focus is on improving cheek skin in those with moderate changes such as dullness, uneven tone, or fine lines. Ideal participants are women who have been on GLP-1 medication for at least six months or have never used it, have maintained a stable weight, and have a BMI of 27 or less. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Do I need to stop taking my current medications for the trial?

The trial requires that participants on GLP-1 agonist medication continue their stable dose. The protocol does not specify if you need to stop other medications, but you should maintain your current skincare routine.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that microdroplet hyaluronic acid fillers are generally safe. Studies have found that these fillers can improve skin by enhancing hydration and firmness. Users have reported better-looking skin, with only minor side effects.

The treatment has been used without serious problems. Most individuals experienced only mild issues, such as slight swelling or redness at the injection site, which typically resolves quickly.

Overall, evidence suggests that microdroplet hyaluronic acid fillers are well-tolerated. Their approval for use in facial treatments further supports their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard wrinkle treatments like creams, laser therapies, or traditional fillers, the microdroplet hyaluronic acid filler offers a unique approach. This treatment uses tiny droplets of hyaluronic acid, which is a naturally occurring substance in the skin, to deliver more precise and even results. Researchers are excited because this method promises smoother, more natural-looking skin with potentially longer-lasting effects, minimizing the need for frequent touch-ups. Plus, it could be particularly beneficial for those already on GLP-1 agonist medications, a group that traditionally hasn't been specifically targeted by wrinkle treatments.

What evidence suggests that microdroplet hyaluronic acid filler is effective for improving skin quality in patients undergoing medical weight loss with GLP-1 therapy?

Research has shown that microdroplet hyaluronic acid fillers, such as SKINVIVE™ by JUVÉDERM®, can significantly enhance facial skin quality. Studies indicate that this treatment increases skin hydration, firms the skin, and reduces signs of tiredness. In one study, 57.9% of patients observed at least a 1-point improvement in cheek smoothness after one month. These results are promising, especially since the effects can last up to six months. In this trial, participants will receive microdroplet hyaluronic acid filler treatment to the cheeks, with one group consisting of GLP-1 patients and another of non-GLP-1 patients. Overall, microdroplet hyaluronic acid fillers appear effective for improving skin quality. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adult women aged 25-50 with moderate skin changes who are on a stable dose of GLP-1 agonist medication for weight loss, or haven't used it in the last year. They must have a BMI of 27 or less, maintain their current skincare routine and weight within a 10% change, and use birth control if applicable.

Inclusion Criteria

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

Participants must maintain a stable weight, defined as no greater than a 10% weight change from screening/baseline and throughout the study

Exclusion Criteria

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

Presence of severe facial skin aging or minimal facial skin aging as defined by Modified Griffiths' Scale

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one treatment with microdroplet hyaluronic acid filler to the cheeks

1 day

1 visit (in-person)

Follow-up

Participants are monitored for skin quality and biomarker changes with follow-up visits including standardized 2D photography and assessments

10 weeks

3 visits (in-person) at Day 30, Day 60, and Day 70

What Are the Treatments Tested in This Trial?

Interventions

• Microdroplet Hyaluronic Acid Filler

Trial Overview

The trial tests SKINVIVE™ microdroplet hyaluronic acid filler's impact on cheek skin quality in patients using GLP-1 therapy for medical weight loss. Participants will undergo treatment to see if it improves skin affected by wrinkles or laxity.

How Is the Trial Designed?

Group I: NON GLP1 Patients Experimental Treatment 1 Intervention

8 participants who are GLP1 naive will receive one treatment with microdroplet hyaluronic acid filler (SKINVIVE™, JUVÉDERM®, Irvine, CA) to the cheeks.

Group II: GLP1 Patients Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Goldman, Butterwick, Fitzpatrick and Groff

Lead Sponsor

Trials

32

Recruited

660+

Citations

1.

cosmeticinjectables.com

cosmeticinjectables.com/blog/skinvive-by-juvederm-science-results-and-safety-of-the-first-fda-approved-skin-quality-injectable/

What Is SkinVive By JUVÉDERM And How Does It Work?

Primary endpoint: 57.9% of treated participants achieved at least a 1-point improvement in cheek smoothness at 1 month (vs. 4.5% in controls). Sustained results ...

2.

researchgate.net

researchgate.net/publication/369941160_The_Effectiveness_of_Injectable_Hyaluronic_Acid_in_the_Improvement_of_the_Facial_Skin_Quality_A_Systematic_Review

(PDF) The Effectiveness of Injectable Hyaluronic Acid in ...

All types of HA formulations cause a significant improvement in facial skin quality, in terms of hydration, firmness, skin-tiring effect/fatigue, brightness, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10082573/

The Effectiveness of Injectable Hyaluronic Acid in the ...

All studies showed significant improvement in facial skin quality in terms of skin hydration, skin firmness, skin-tiring effect/fatigue, and ...

4.

skinvivebyjuvederm.com

skinvivebyjuvederm.com/

SKINVIVE by JUVÉDERM® | Microdroplet Injectable Treatment

The first and only injectable facial rejuvenation treatment designed to add hydration directly into the skin with results that last up to 6 months.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07221461

Assess Impact of Microdroplet Hyaluronic Acid Filler on ...

24 patients total (16 GLP1 and 8 non-GLP1) will receive one treatment with microdroplet hyaluronic acid filler (SKINVIVE™, JUVÉDERM®, Irvine, ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf11/P110033S059B.pdf

Summary of Safety and Effectiveness Data (SSED)

The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of microdroplet intradermal injections with the ...

7.

drugs.com

drugs.com/skinvive.html

Skinvive by Juvéderm: Uses, Dosage, Side Effects

Skinvive by Juvéderm is a hyaluronic acid dermal filler used to improve skin smoothness of the cheeks, it is given by intradermal microdroplet injection.