[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07217743":3,"trial-entities:NCT07217743":83,"trial-summary:NCT07217743":87},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":40,"secondary_outcomes":45,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":56,"locations":59,"central_contacts":78,"overall_officials":80,"references":81,"see_also_links":82},"NCT07217743","Sculptra-Aesthetic-GLP1","Assess Impact of Poly-L-lactic Acid on GLP1 Subjects","Prospective, Single Center, Open-label Study Assessing Impact of Poly-L-lactic Acid on Adipogenesis in Patients on Glucagon-like Peptide-1 Agonists","NOT_YET_RECRUITING","2026-10-31","2025-10","2025-10-16","2025-10-27","Goldman, Butterwick, Fitzpatrick and Groff","OTHER",false,"Clinical trial to evaluate treatments of double-dilute poly-L-lactic acid on abdominal skin laxity in GLP1 patients versus non GLP1 patients.","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.",[19],"Laxity; Skin",[21,22,23,24],"laxity","loose skin","glp1","abdominal laxity","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},20,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Sculptra Aesthetic","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.",[38,39],"GLP1 Patients","NON GLP1 Patients",[41],{"measure":42,"description":43,"timeFrame":44},"Physical Global Aesthetic Improvement Scale","Assess improvement of Abdominal skin laxity:\n\nMuch Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2","Month 3 and Month 9",[46],{"measure":47,"description":43,"timeFrame":44},"Subject Global Aesthetic Improvement Scale","FEMALE","25 Years","65 Years",true,{"inclusion":53,"exclusion":54,"raw_text":55},[],[],"Inclusion Criteria:\n\n1. Adult women aged 25-65 years.\n2. Fitzpatrick skin types I-IV.\n3. Presence of mild to moderate skin laxity of abdomen, as determined by clinical investigators.\n4. Stable weight for 3 months, with body mass index (BMI) of 27 or less.\n5. 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.\n6. Must be willing to sign a photography release and ICF, and complete the entire course of the study.\n7. Subjects in good general health based on investigator's judgment and medical history.\n8. Negative urine pregnancy test result at the time of study entry (if applicable).\n9. 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.\n\n   1. Acceptable forms of birth control are: oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device\u002Fcoil, double-barrier methods (e.g., sponge, spermicide, or condoms). Abstinence and\u002For vasectomized partner must agree to a second acceptable method of birth control (double-barrier) should the subject become sexually active.\n   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\u002For both ovaries (oophorectomy), or bilateral tubal ligation.\n\nExclusion Criteria:\n\n1. The presence of severe abdominal skin laxity as determined by clinical investigators.\n2. Still actively losing weight.\n3. Pregnancy or planned pregnancy during the study or currently breastfeeding.\n4. Any uncontrolled systemic disease.\n5. History of autoimmune connective tissue disease.\n6. Current use of immunosuppressive medication.\n7. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.\n8. Active dermatitis or active infection in the proposed treatment area.\n9. 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.\n10. Any investigational treatment for skin quality of the abdomen during the 12-month period before the study treatment\n11. Creams\u002Fcosmeceuticals and\u002For home therapies for the prevention or treatment of skin quality in the treatment area during the 1-month period before study treatment\n12. 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.\n13. Subjects who spray tanned or used sunless tanners in the treatment areas 1-month prior to study treatment.\n14. 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\u002For current pregnancy or breastfeeding .\n15. Inability to ambulate following the procedure.\n16. History of lidocaine and\u002For epinephrine sensitivity deemed by the investigator to preclude subject from enrolling into study.\n17. Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study.\n18. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":75},"West Dermatology Research Center","San Diego","California","92121","United States",[67,72],{"name":68,"role":69,"phone":70,"email":71},"Andrea Pacheco","CONTACT","858-657-1004","apacheco@clderm.com",{"name":73,"role":69,"phone":70,"email":74},"Freia Canals-Cistero","freia.canals-cistero@platinumderm.com",{"lat":76,"lon":77},32.71571,-117.16472,[79],{"name":68,"role":69,"phone":70,"email":71},[],[],[],{"nct_id":4,"conditions":84,"biomarkers":86},[85],"Cutis Laxa",[],{"nct_id":4,"found":51,"summary":88,"prompt_version":98},{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an interventional study involving 20 women, with 15 taking GLP-1 medication and 5 not. All participants will receive Sculptra Aesthetic.","completed","Sculptra for Abdominal Skin Laxity in GLP-1 Users","This study is looking at how Sculptra Aesthetic, a treatment for skin laxity, works on the abdomen of women. Researchers want to see if Sculptra helps improve loose skin in women who are taking GLP-1 agonist medications (used for conditions like diabetes or weight management), compared to women who are not on these medications. You might be able to join if you are a woman between 25 and 65 years old with mild to moderate loose skin on your abdomen, a stable weight, and a BMI of 27 or less. If you are on a GLP-1 medication, you must have been on a stable dose for at least 6 months. The main goal is to see how much the skin improves after 3 and 9 months. The current status of this study is unclear, and it plans to enroll 20 participants.","Participants will be followed for 9 months after their initial treatment.",141,"Participants will receive three treatments of Sculptra Aesthetic to the abdomen, one month apart. You will also have follow-up visits at month 3 and month 9 for photography and assessments.","Not stated in the trial record.",[35],"v2"]