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| ID | Type | Description | Link |
|---|---|---|---|
| PuNanPLLA-001 | Other Identifier | PuNan Hospital |
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Following weight loss with GLP-1 receptor agonists, facial skin laxity and sagging have become another concern for some patients. The temples, cheeks, tear troughs, jawline, marionette lines, and nasolabial folds are the most common areas of volume loss or wrinkles after semaglutide treatment. Restoring facial volume after discontinuing weight-loss medications poses a challenge, as the sole use of hyaluronic acid or permanent fillers may lead to a significant number of patients requiring corrective treatment for overfilled facial syndrome.Poly-L-lactic acid (PLLA) works by releasing low concentrations of lactic acid to stimulate fibroblast-mediated collagen synthesis. Additionally, macrophages participate in the collagen production process triggered by lactic acid, ultimately improving skin laxity. This study aims to evaluate the safety and efficacy of PLLA injections in addressing facial laxity following GLP-1 analogue therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poly-l-lactic acid injection | Experimental | Poly-L-lactic acid (PLLA) lyophilized powder is reconstituted with normal saline for facial injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLLA injection | Device | Poly-L-lactic acid (PLLA) lyophilized powder, after reconstitution with normal saline, is injected into the subcutaneous layer of the face. Three treatment sessions delivered at 4-week intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| WSRS (Wrinkle Severity Rating Scale) Assessment | Compare baseline and post-treatment scores to evaluate improvement in nasolabial folds and marionette lines.
| At screening, before each treatment session, and at 4, 12, 24 and 48 weeks after the final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| GAIS (Global Aesthetic Improvement Scale) Assessment | Investigator-evaluated and subject-evaluated overall aesthetic improvement post-treatment. Statistics include the proportion of subjects with: Grade 1 (very significant improvement), Grade 2 (significant improvement), and Grade 3 (some improvement). | At 4, 12, 24 and 48 weeks after the final treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Punan Hospital of Pudong New District | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39098289 | Background | Mansour MR, Hannawa OM, Yaldo MM, Nageeb EM, Chaiyasate K. The rise of "Ozempic Face": Analyzing trends and treatment challenges associated with rapid facial weight loss induced by GLP-1 agonists. J Plast Reconstr Aesthet Surg. 2024 Sep;96:225-227. doi: 10.1016/j.bjps.2024.07.051. Epub 2024 Jul 25. No abstract available. | |
| 39339028 |
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| Skin Elasticity | Skin elasticity changes evaluated using a cutometer | At baseline and 24 weeks post-final treatment |
| Signori R, Barbosa AP, Cezar-Dos-Santos F, Carbone AC, Ventura S, Nobre BBS, Neves MLBB, Camara-Souza MB, Poluha RL, De la Torre Canales G. Efficacy and Safety of Poly-l-Lactic Acid in Facial Aesthetics: A Systematic Review. Polymers (Basel). 2024 Sep 11;16(18):2564. doi: 10.3390/polym16182564. |
| 37786340 | Background | Avelar L, Ong A, Ong D, Wai ACS, Wai AYT, Sungkyu J, Seok LH, Tam E, Leng SE, Huang J, Chao Y, Brasater D, Prygova I. Consensus recommendations on the use of injectable poly-l-lactic acid in Asian patients. J Cosmet Dermatol. 2023 Dec;22(12):3223-3231. doi: 10.1111/jocd.15969. Epub 2023 Oct 2. |