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Randomized Controlled Pilot Study of PLLA Injection for the Improvement of Abdominal Skin Laxity in the Chinese Population

Randomized Controlled Pilot Study of PLLA Injection for the Improvement of Abdominal Skin Laxity in the Chinese Population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128957
Enrollment
Unknown
Registered
2026-07-28
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired abdominal skin laxity, accompanied by degenerative loss of dermal collagen and elastic fibers, soft tissue sagging

Interventions

PLLA injection intervention group:Abdominal subcutaneous layer-by-layer injection of L-lysine lactate for anti-aging treatment. The PLLA was re-dissolved in sterile injection water. One bottle of PLLA
Control Group:There was no PLLA injection intervention in the early stage. The follow-up started from the baseline and lasted until 24 weeks. GAIS scores, dermal thickness measurement by ultrasound, e

Sponsors

Tongji Hospital of Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 50 years, with previous good health. 2. Abdominal skin laxity assessed by Visual grading of skin sagging as Grade 2/Grade 3 (Hadded et al., 2025). 3. 18.5 kg/m^2 >= BMI >= 24.9 kg/m^2 (Hadded et al., 2025). 4. Good compliance and agreement to complete follow-up. 5. Willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Has a major disease such as a history of malignancy, use of anticoagulant drugs, or acute dermatitis at the treatment site, etc. 2. Has delivered a baby within the past 6 months (Benjamin DR, 2014). 3. Is pregnant, breastfeeding, or plans to become pregnant within 1 year. 4. Has previously undergone abdominal contouring surgery. 5. Has received abdominal photoelectric treatments (including laser and light-based devices, radiofrequency energy devices, ultrasound devices, etc.) within the past 1 month. 6. Has received or is expected to receive other injectable products (including biostimulators, collagen, hyaluronic acid, etc.) in the abdominal area within the past 3 months. 7. Has no plans for significant weight loss or major changes in fitness habits within the next 12 months. 8. Has an umbilical hernia detected by abdominal ultrasound examination. 9. Other conditions that the investigator considers unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Global Aesthetic Improvement Scale (GAIS) score of abdominal skin;

Secondary

MeasureTime frame
Abdominal dermal thickness measured via ultrasound;Abdominal skin elasticity tested by Cutometer;The number, frequency and incidence rate of adverse events and adverse reactions;Instances such as equipment breakage and product damage occurred;

Countries

China

Contacts

Public ContactCui Haiyan

Tongji Hospital of Tongji University

u2beauty1@sina.com+86 21 56051080

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026