Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Juläine™ in Improving Gluteal Skin Laxity in Adults.

This study aims to evaluate the safety and effectiveness of Juläine™ (poly-L-lactic acid) injections for the treatment of buttock skin laxity. Participants will be randomized to an immediate-treatment group or a delayed-treatment group. The immediate-treatment group will receive 2 to 3 treatment sessions over up to 2 months and will be compared with the delayed-treatment group during the control period; the delayed-treatment group will receive the same treatment after the delay. The primary objective is to assess clinical improvement in buttock skin elasticity 6 months after the last treatment, defined as an increase in skin elasticity measured by a cutometer. Total study participation is up to 16 months, including follow-up. This multicenter trial will be conducted in Brazil.

NCT Number	NCT07332650
Lead Sponsor	Nordberg Medical AB
Conditions	Skin Quality, Skin Laxity
Enrollment	100 participants
Start Date	2026-10
Primary Completion	2027-04 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-19