PLLA-LASYNPRO™ Injections for Skin Laxity Treatment
Recruiting
N/A
Interventional Study
Skin Laxity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- Nordberg Medical Italy srl · Industry
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About This Trial
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. Each participant will serve as his or her own control, with one thigh treated with PL…
Trial Locations
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Eligibility Criteria
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 sur…
Contacts