Study on the Efficacy and Safety of PLLA Injections for Improving Facial Laxity Following GLP-1 A… (NCT07478198) | Clinical Trial Compass
By InvitationNot Applicable
Study on the Efficacy and Safety of PLLA Injections for Improving Facial Laxity Following GLP-1 Analog Therapy
China22 participantsStarted 2025-07-03
Plain-language summary
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.
Who can participate
Age range30 Years – 60 Years
SexALL
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Inclusion criteria
✓. Adults who have received GLP-1 analog therapy and experienced significant weight loss (BMI reduction ≥ 5%).
✓. Aged 30 to 60 years, with noticeable facial sagging, and nasolabial folds or marionette lines rated 2 to 4 on the Wrinkle Severity Rating Scale (WSRS).
✓. Subjects who have fully understood the clinical trial protocol and associated risks, voluntarily signed the informed consent form, and expressed willingness to undergo facial injection treatment.
Exclusion criteria
✕. Known or previous allergy or hypersensitivity to any component of the product.
✕. Known or previous allergy to local anesthetics (e.g., lidocaine or other amide-type anesthetics).
✕. History of severe or multiple allergies, such as severe systemic anaphylactic reactions.
✕. Previous surgery (including cosmetic surgical procedures or liposuction), piercings, or tattoos in the area to be treated.
✕. Prior tissue filler treatments or contouring in the area to be treated, including the use of any permanent fillers, or any semi-permanent fillers, autologous fat, lifting threads, or permanent implants within 24 months before treatment.
What they're measuring
1
WSRS (Wrinkle Severity Rating Scale) Assessment
Timeframe: At screening, before each treatment session, and at 4, 12, 24 and 48 weeks after the final treatment
Trial details
NCT IDNCT07478198
SponsorShanghai Punan Hospital of Pudong New District
✕. Use of any biodegradable facial tissue fillers based on hyaluronic acid or collagen in the area to be treated within 12 months before treatment.
✕. Botulinum toxin injections in the area to be treated within 6 months before treatment.
✕. Presence of any disease or lesion in or near the area to be treated, such as inflammation, active or chronic infection (e.g., in the oral, head, and neck regions); facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes simplex, or herpes zoster; scars or deformities; cancer or precancerous lesions (e.g., actinic keratosis).