WrinklePhase 2NCT07221461
Assess Impact of Microdroplet Hyaluronic Acid Filler on Skin Quality in Patients on Glucagon-like Peptide-1 Agonists
A Phase 2 study testing Skinvive in people with Wrinkle, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Skinvive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 2 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- 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. 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.
Who cannot join
- 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.
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- 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.
- History of lidocaine and/or tetracaine sensitivity deemed by the investigator to preclude subject from enrolling into study.
- Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study.
- Subjects planning any cosmetic procedure to the treatment area during the study period, other than the treatment that will be performed by the investigator.
- Use of topical steroids, retinoids/retinols, or vitamin C to the face within the previous 2-weeks of screening.
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
West Dermatology Research Center
San Diego, California, 92121
Andrea Pacheco, 858-657-1004, apacheco@clderm.com
Freia Canals-Cistero, 858-657-1004, freia.canals-cistero@platinumderm.com
About this study
Official title: 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
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.
- Conditions
- Wrinkle
- Being tested
- Skinvive
- Keywords
- skin laxity, fine lines, dull skin, uneven skin tone
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkinviveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Skinvive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Fine Lines
Score 0 no fine lines thru 9 numerous, many fine lines
Measured: Screening, Day 30, Day 60
Overall Hyperpigmentation
Score 0= no hyperpigmentation thru 9= significant hyperpigmentation
Measured: Screening, Day 30, Day 60
Skin Tone Evenness
Score 0= Very even tone thru Score 9= Uneven, discolored appearance (brown and/or red colors)
Measured: Screening, Day 30, Day 60
Skin Firmness
Score 0= Firm, tight feeling skin thru Score 9= Loose, lax feeling skin
Measured: 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
Measured: 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
Measured: 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
Measured: Screening, Day 30, Day 60
Secondary outcomes (2)
Physical Global Aesthetic Improvement Scale
Assess improvement of Abdominal skin laxity:
Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2
Measured: Day 30 and Day 60
Subject Global Aesthetic Improvement Scale
Assess improvement of Abdominal skin laxity:
Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2
Measured: Day 30 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion2 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All subjects (16 GLP1 and 8 non-GLP1) will receive one treatment with microdroplet hyaluronic acid filler (SKINVIVE™, JUVÉDERM®, Irvine, CA) to the cheeks.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221461
- Sponsor's protocol ID
- Skinvive GLP1 agonist
- Status last verified
- Oct 2025
- First submitted
- 24 Oct 2025
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07221461
- Acronym / sponsor ID
- Skinvive GLP1 agonist
- Conditions
- Wrinkle
- Keywords
- skin laxity, fine lines, dull skin, uneven skin tone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 2 Mar 2026 (estimated)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All subjects (16 GLP1 and 8 non-GLP1) will receive one treatment with microdroplet hyaluronic acid filler (SKINVIVE™, JUVÉDERM®, Irvine, CA) to the cheeks.
| Arm | Type | Receives |
|---|---|---|
| GLP1 Patients | Active comparator | Device: Skinvive16 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. |
| NON GLP1 Patients | Experimental | Device: Skinvive8 participants who are GLP1 naive will receive one treatment with microdroplet hyaluronic acid filler (SKINVIVE™, JUVÉDERM®, Irvine, CA) to the cheeks. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skinvive16 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. | Device | GLP1 Patients, NON GLP1 Patients |
Primary outcome
Global Fine Lines
Time frame: Screening, Day 30, Day 60
Score 0 no fine lines thru 9 numerous, many fine lines
Overall Hyperpigmentation
Time frame: Screening, Day 30, Day 60
Score 0= no hyperpigmentation thru 9= significant hyperpigmentation
Skin Tone Evenness
Time frame: Screening, Day 30, Day 60
Score 0= Very even tone thru Score 9= Uneven, discolored appearance (brown and/or red colors)
Skin Firmness
Time frame: Screening, Day 30, Day 60
Score 0= Firm, tight feeling skin thru Score 9= Loose, lax feeling skin
Skin Radiance/ Brightness
Time frame: Screening, Day 30, Day 60
Score 0= Very radiant, luminous or glowing appearance thru Score 9= Very dull/ matte and/or sallow skin appearance
Skin Texture Smoothness
Time frame: Screening, Day 30, Day 60
Score 0= Very smooth, even-looking skin texture, no roughness thru Score 9= Very rough, pronounced, extensive visible skin roughness
Global Wrinkles
Time frame: Screening, Day 30, Day 60
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
2 secondary outcomes
Physical Global Aesthetic Improvement Scale
Time frame: Day 30 and Day 60
Subject Global Aesthetic Improvement Scale
Time frame: Day 30 and Day 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Skinvive in people with Wrinkle, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pacheco (858-657-1004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Fine Lines (time frame: Screening, Day 30, Day 60). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.