PLLA LASYNPRO Injections for Skin Tightening After Weight Loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label, intra-subject controlled proof-of-concept study evaluating histological and clinical effects of PLLA LASYNPRO injections for post-bariatric skin laxity. Fifteen participants will receive three injections in one thigh over about three months, while the other thigh remains untreated. Tissue samples will be collected during planned plastic surgery at 3–9 months after the last injection to compare treated and untreated areas, focusing on collagen I and III changes. A follow-up visit occurs about 30 days after surgery to assess outcomes. The trial aims to determine whether PLLA LASYNPRO can induce histological and clinical improvements in skin laxity after substantial weight loss.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female aged ≤ 60 years
* Previous bariatric surgery (one anastomosis gastric bypass)
* Stable weight for at least 6 months prior to baseline
* Post-weight loss skin laxity and ptosis requiring surgery
* ΔBMI ≥ 7 defined as the change in BMI from scheduled bariatric surgery to baseline
* BMI ≤ 30
* Pittsburgh scale rating ≥10
* Ability to give written informed consent
* Willing to participate in the study and attending the visits

Exclusion Criteria:

* Skin infection or skin inflammation status
* Acute or chronic skin disease
* ΔBMI \< 7 defined as the change in BMI from scheduled bariatric surgery to baseline
* BMI \> 30
* Male or female aged 60 \> years
* Pregnancy and lactating; if a female is of childbearing potential, she should have a negative pregnancy test and should use a highly effective method to avoid pregnancy for the duration of the trial
* Any clinically significant findings, as determined by the investigator, from laboratory tests and individual patient's medical history, that may contraindicate post-bariatric surgery for the patient
* History of allergies to any of the constituents of the product
* Haemorrhagic disease or under anticoagulant therapy
* Have a known history of or susceptibility to keloid formation or hypertrophic scarring
* Immune deficiencies

Where it's running

• Azienda Ospedaliero Universitaria Senese
  Siena, Italy Recruiting

Study contacts

• Principal investigator: R. Cuomo — Azienda Ospedaliera Universitaria Senese
• Study coordinator: A.Piovani (Evidence Generation Project Manager)
• Email: arianna.piovani@evidilya.com
• Phone: +39 0249530047

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.