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.
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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

A.Piovani (Evidence Generation Project Manager)

+39 0249530047

arianna.piovani@evidilya.com

CONTACT