Assess Impact of Poly-L-lactic Acid on GLP1 Subjects

NCT07217743 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: Sculptra-Aesthetic-GLP1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical trial to evaluate treatments of double-dilute poly-L-lactic acid on abdominal skin laxity in GLP1 patients versus non GLP1 patients.

Conditions

Laxity; Skin

Keywords

laxity; loose skin; glp1; abdominal laxity

Outcome Measures

Primary 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

  Month 3 and Month 9

Secondary Outcomes (1)

• Subject Global Aesthetic Improvement Scale

  Month 3 and Month 9

Study Arms (2)

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.

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.

Device: Sculptra Aesthetic

Interventions

Sculptra Aesthetic DEVICE

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.

GLP1 Patients; NON GLP1 Patients

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: Female at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

Study Sites (1)

West Dermatology Research Center

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Andrea Pacheco

CONTACT

858-657-1004; apacheco@clderm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects (15 GLP1 and 5 non GLP1) will receive three treatments, one month apart, of Sculptra Aesthetic to the abdomen.

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 16, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Locations

US (1)