Laxity; SkinPhase 2NCT07217743
Assess Impact of Poly-L-lactic Acid on GLP1 Subjects
A Phase 2 study testing Sculptra Aesthetic in people with Laxity; Skin, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
Clinical trial to evaluate treatments of double-dilute poly-L-lactic acid on abdominal skin laxity in GLP1 patients versus non GLP1 patients. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laxity; Skin
- What is being tested?
- Sculptra Aesthetic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to 31 Oct 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult women aged 25-65 years.
- Fitzpatrick skin types I-IV.
- Presence of mild to moderate skin laxity of abdomen, as determined by clinical investigators.
- Stable weight for 3 months, with body mass index (BMI) of 27 or less.
- Current treatment with a stable dose of GLP-1 agonist medication for at least the last 6 months, for 15 of the enrolled subjects. Remaining 5 subjects should not be taking or have a history of taking a GLP-1 agonist medication, and should not be planning to take a GLP-1 in the foreseeable future.
- Must be willing to sign a photography release and ICF, and complete the entire course of the study.
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- 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).
- Subjects of childbearing potential must agree to use an effective 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 forms of birth control are: oral contraceptive pill, injection, implant, patch, vaginal ring, 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.
Who cannot join
- The presence of severe abdominal skin laxity as determined by clinical investigators.
- Still actively losing weight.
- Pregnancy or planned pregnancy during the study or currently breastfeeding.
- Any uncontrolled systemic disease.
- History of autoimmune connective tissue disease.
- Current use of immunosuppressive medication.
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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 or active infection in the proposed treatment area.
- 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.
- Any investigational treatment for skin quality of the abdomen during the 12-month period before the study treatment
- Creams/cosmeceuticals and/or home therapies for the prevention or treatment of skin quality in the treatment area during the 1-month period before study treatment
- Subjects with scarring in the treatment areas, including laparoscopic or abdominal surgery scars, which in the opinion of the investigator could impact results. Subjects with a history of keloids will be excluded.
- Subjects who spray tanned or used sunless tanners in the treatment areas 1-month 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 epinephrine 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.
- 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 Poly-L-lactic Acid on Adipogenesis in Patients on Glucagon-like Peptide-1 Agonists
Clinical trial to evaluate treatments of double-dilute poly-L-lactic acid on abdominal skin laxity in GLP1 patients versus non GLP1 patients.
Read the detailed description
20 patients total (15 GLP1 and 5 non-GLP1) will receive three treatments of double-dilute PLLA (Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX) to the abdomen one month apart. Using a 22 G 2" cannula, up to 16cc of poly-L-lactic acid will be used per treatment. Patients will return for follow up visits at month 3 and month 9, where they will undergo standardized 2D photography and assessments.
- Conditions
- Laxity; Skin
- Being tested
- Sculptra Aesthetic
- Keywords
- laxity, loose skin, glp1, abdominal laxity
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra AestheticDevice
15 GLP1 subjects treated with Sculptra to their abdomen for skin laxity will be compared to 5 non GLP1 subjects treated with Sculptra for skin laxity.
| Study group | Role | What they receive |
|---|---|---|
| GLP1 Patients | Active comparator | 15 Participants who have been on a stable dose of GLP1 for at least 6 months will receive three treatments, one month apart, of Sculptra Aesthetic up to 16cc. Receives: Device: Sculptra Aesthetic |
| NON GLP1 Patients | Experimental | 5 participants who are GLP1 naive will receive three treatments, one month apart, of Sculptra Aesthetic up to 16cc. Receives: Device: Sculptra Aesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Month 3 and Month 9
Secondary outcomes (1)
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: Month 3 and Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start27 Oct 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laxity; SkinStudies 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 (15 GLP1 and 5 non GLP1) will receive three treatments, one month apart, of Sculptra Aesthetic to the abdomen.
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07217743
- Sponsor's protocol ID
- Sculptra-Aesthetic-GLP1
- Status last verified
- Oct 2025
- First submitted
- 14 Oct 2025
- Last updated
- 16 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 16 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 Poly-L-lactic Acid on Adipogenesis in Patients on Glucagon-like Peptide-1 Agonists
- ClinicalTrials.gov ID
- NCT07217743
- Acronym / sponsor ID
- Sculptra-Aesthetic-GLP1
- Conditions
- Laxity; Skin
- Keywords
- laxity, loose skin, glp1, abdominal laxity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 27 Oct 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 16 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 evaluate treatments of double-dilute poly-L-lactic acid on abdominal skin laxity in GLP1 patients versus non GLP1 patients.
Detailed description
20 patients total (15 GLP1 and 5 non-GLP1) will receive three treatments of double-dilute PLLA (Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX) to the abdomen one month apart. Using a 22 G 2" cannula, up to 16cc of poly-L-lactic acid will be used per treatment. Patients will return for follow up visits at month 3 and month 9, where they will undergo standardized 2D 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 (15 GLP1 and 5 non GLP1) will receive three treatments, one month apart, of Sculptra Aesthetic to the abdomen.
| Arm | Type | Receives |
|---|---|---|
| GLP1 Patients | Active comparator | Device: Sculptra Aesthetic15 Participants who have been on a stable dose of GLP1 for at least 6 months will receive three treatments, one month apart, of Sculptra Aesthetic up to 16cc. |
| NON GLP1 Patients | Experimental | Device: Sculptra Aesthetic5 participants who are GLP1 naive will receive three treatments, one month apart, of Sculptra Aesthetic up to 16cc. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult women aged 25-65 years.
- Fitzpatrick skin types I-IV.
- Presence of mild to moderate skin laxity of abdomen, as determined by clinical investigators.
- Stable weight for 3 months, with body mass index (BMI) of 27 or less.
- Current treatment with a stable dose of GLP-1 agonist medication for at least the last 6 months, for 15 of the enrolled subjects. Remaining 5 subjects should not be taking or have a history of taking a GLP-1 agonist medication, and should not be planning to take a GLP-1 in the foreseeable future.
Key exclusion criteria (18 listed)
- The presence of severe abdominal skin laxity as determined by clinical investigators.
- Still actively losing weight.
- Pregnancy or planned pregnancy during the study or currently breastfeeding.
- Any uncontrolled systemic disease.
- History of autoimmune connective tissue disease.
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 |
|---|---|---|
| Sculptra Aesthetic15 GLP1 subjects treated with Sculptra to their abdomen for skin laxity will be compared to 5 non GLP1 subjects treated with Sculptra for skin laxity. | Device | GLP1 Patients, NON GLP1 Patients |
Primary outcome
Physical Global Aesthetic Improvement Scale
Time frame: Month 3 and Month 9
Assess improvement of Abdominal skin laxity: Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2
1 secondary outcome
Subject Global Aesthetic Improvement Scale
Time frame: Month 3 and Month 9
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 16 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 Sculptra Aesthetic in people with Laxity; Skin, 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 11 inclusion and 18 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 16 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?
Physical Global Aesthetic Improvement Scale (time frame: Month 3 and Month 9). 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 16 Oct 2025.