Prospective, Single Center, Open-label Study Assessing Impact of Poly-L-lactic Acid on Adipogenesis in Patients on Glucagon-like Peptide-1 Agonists
Goldman, Butterwick, Fitzpatrick and Groff
Summary
Clinical trial to evaluate treatments of double-dilute poly-L-lactic acid on abdominal skin laxity in GLP1 patients versus non GLP1 patients.
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.
Eligibility
- Age range
- 25–65 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Adult women aged 25-65 years. 2. Fitzpatrick skin types I-IV. 3. Presence of mild to moderate skin laxity of abdomen, as determined by clinical investigators. 4. Stable weight for 3 months, with body mass index (BMI) of 27 or less. 5. 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. 6. Must be willing to sign a photography re…
Interventions
- DeviceSculptra 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.
Location
- West Dermatology Research CenterSan Diego, California