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Facial Skin LaxityPLLA-GLP-1NCT07478198

Study on the Efficacy and Safety of PLLA Injections for Improving Facial Laxity Following GLP-1 Analog Therapy

A study testing PLLA injection in people with Facial Skin Laxity, run by Shanghai Punan Hospital of Pudong New District at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Facial Skin Laxity
What is being tested?
PLLA injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
3 Jul 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Use of any biodegradable facial tissue fillers based on hyaluronic acid or collagen in the area to be treated within 12 months before treatment.
Show all 19Show fewer
  • 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).
  • Past or current active collagen diseases, e.g., systemic lupus erythematosus, rheumatoid arthritis, polymyositis, dermatomyositis, or localized or systemic scleroderma.
  • Predisposition to keloid formation, hypertrophic scarring, or any other abnormal healing.
  • History of bleeding disorders or, in the investigator's judgment, treatment with thrombolytics, anticoagulants, or platelet aggregation inhibitors within a relevant period before treatment.
  • Treatment with chemotherapy, immunosuppressants, immunomodulatory therapies (e.g., monoclonal antibodies), or systemic corticosteroids (inhaled corticosteroids are permitted) within 3 months before treatment.
  • Treatment with topical (below the infraorbital rim) retinoids or corticosteroids within 1 month before treatment, or systemic retinoids within 6 months before treatment.
  • Any medical condition that, in the investigator's opinion, makes the subject unsuitable for inclusion.
  • Other conditions that, in the investigator's opinion, preclude the subject from participating in the study, e.g., subjects who may be unable to avoid other facial cosmetic treatments, subjects deemed potentially unreliable, unreachable, unable to understand study assessments, or with unrealistic expectations regarding treatment outcomes.
  • Pregnant or breastfeeding women, women of childbearing potential not using adequate contraception, or women planning pregnancy during the study period.
  • Subjects planning to undergo any other facial plastic surgery or cosmetic procedures (e.g., laser or chemical peels, microneedling, facelifts, radiofrequency treatments, etc.) below the infraorbital rim during the entire study period.
  • Moderate to severe asymmetry in the midface assessment, i.e., a difference of more than 1 grade in the WSRS ratings between the two sides of the face.
  • Intentional significant weight change (BMI change ≥ 2) during the study period.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Shanghai Punan Hospital of Pudong New District

    Shanghai, Shanghai Municipality

Other trials in China

About this study

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.

Being tested
PLLA injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLLA injectionDevice

    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.

Study groups in NCT07478198
Study groupRoleWhat they receive
Poly-l-lactic acid injectionExperimentalPoly-L-lactic acid (PLLA) lyophilized powder is reconstituted with normal saline for facial injection
Receives: Device: PLLA injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WSRS (Wrinkle Severity Rating Scale) Assessment

    Compare baseline and post-treatment scores to evaluate improvement in nasolabial folds and marionette lines.

    1. Score improvement between baseline and post-treatment;
    2. Percentage of subjects achieving ≥1-grade improvement.

    Measured: At screening, before each treatment session, and at 4, 12, 24 and 48 weeks after the final treatment

Secondary outcomes (2)

  1. 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).

    Measured: At 4, 12, 24 and 48 weeks after the final treatment

  2. Skin Elasticity

    Skin elasticity changes evaluated using a cutometer

    Measured: At baseline and 24 weeks post-final treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start3 Jul 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07478198
Sponsor's protocol ID
PuNan2024-028
Other IDs
PuNanPLLA-001
Acronym
PLLA-GLP-1
Status last verified
Dec 2025
First submitted
12 Mar 2026
Last updated
17 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39098289

  • 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.

    PubMed 39339028

  • 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.

    PubMed 37786340

Questions about this trial

What is this clinical trial studying?

A study testing PLLA injection in people with Facial Skin Laxity, run by Shanghai Punan Hospital of Pudong New District at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WSRS (Wrinkle Severity Rating Scale) Assessment (time frame: At screening, before each treatment session, and at 4, 12, 24 and 48 weeks after the final treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07478198, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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