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New treatment option for Skin Laxity
Official title PLLA-LASYNPRO™ Injections for Skin Laxity Treatment
ClinicalTrials.gov ID: NCT07637188
What this study is testing
- What it's testing
- This single-center, open-label, intra-subject controlled proof-of-concept clinical study will evaluate the histological and clinical effects of Poly-L-lactic Acid (PLLA) LASYNPRO™ (Juläine) injections for treatment of skin laxity in patients requiring post-bariatric surgery. Fifteen participants will be enrolled.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Siena, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Siena, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.