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.
This is an pivotal, open-label, two-arm, randomized, parallel-group, prospective clinical investigation conducted in Brazil to evaluate the safety and effectiveness of Juläine™ (poly-L-lactic acid) administered as intradermal injections for the treatment skin laxity in the buttock (gluteal) region in adults. A total of 100 participants will be randomized to either an immediate-treatment group or a delayed-treatment group (delayed-start control). Participants in the immediate-treatment group will receive Juläine™ intradermal injections in up to three sessions at Day 0, Day 30, and Day 60. During this initial control period, outcomes in the immediate-treatment group will be compared with those in the delayed-treatment group, which will not receive treatment. After the control period, participants in the delayed-treatment group will receive the same Juläine™ regimen at Day 240, Day 270, and Day 300. Each participant will remain in the study for up to 16 months, including screening, treatment sessions, and follow-up assessments. The primary efficacy endpoint is improvement in buttock skin elasticity 6 months after the enrolment defined as an increase in global skin elasticity measured by a cutometer, with assessments at screening/baseline and at the primary post-treatment timepoint. The mean change in global skin elasticity measured by cutometer and Global Aesthetic Improvement Scale (GAIS) will also be evaluated, comparing groups during the control period. Safety will be monitored through the collection of adverse events (AEs) through 240 days after screening, with comparisons between groups during the control period. Adverse events will also be evaluated through extended follow-up, including up to 180 days in the overall study population and up to 480 days in the immediate-treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Juläine™ is a sterile injectable medical device composed of polylactic acid microspheres.
Proportion of participants who achieve an improvement in gluteal skin elasticity
Proportion of participants achieving a clinically significant reduction in gluteal skin laxity at Day 240 after randomization, whereby a clinically significant reduction ("response") is defined as a relative increase of at least 10% in the gross elasticity measured by cutometer at Day 240 compared to baseline.
Time frame: Baseline and 240 days after randomization
Mean change in overall skin elasticity
Mean change in global medial skin elasticity measured by cutometer 180 days after treatment completion.
Time frame: Baseline and Day 240 after randomization.
Global improvement based on Global Aesthetic Improvement Scale (GAIS) evaluated by investigator
Proportion of participants with at least a 1-point improvement in GAIS as rated by the investigator at Day 240 after randomization. The GAIS scale values are: 1. Very much improved 2. Much improved 3. Improved 4. No change 5. Worse Where 1 represents the best outcome and 5 represents the worst.
Time frame: Baseline and Day 240 after randomization.
Global improvement based on Global Aesthetic Improvement Scale (GAIS) evaluated by participant
Proportion of participants with at least a 1-point improvement in GAIS as rated by the participant at Day 240 after randomization The GAIS scale values are: 1. Very much improved 2. Much improved 3. Improved 4. No change 5. Worse Where 1 represents the best outcome and 5 represents the worst.
Time frame: Baseline and Day 240 after randomization.
Proportion of adverse events (AEs)
Proportion of adverse events (AEs) - excluding expected post-injection local reactions - occurring up to 240 days after the start of treatment, in both treatment groups.
Time frame: Occurring up to 240 days after the start of treatment, in both treatment groups.
Incidence and severity of expected local injection-site reactions in the first 30 days
Incidence and severity of expected local injection-site reactions in the first 30 days after each Juläine™ administration, in all treated participants.
Time frame: First 30 days after each Juläine™ administration, in all treated participants.
Incidence and severity of AEs (excluding expected local post-injection reactions) up to 240 days.
Incidence and severity of AEs (excluding expected local post-injection reactions) up to 240 days after start of treatment in all treated participants.
Time frame: Up to 240 days after start of treatment in all treated participants.
Incidence and severity of AEs (excluding expected local post-injection reactions) up to 480 days
Incidence and severity of AEs (excluding expected local post-injection reactions) up to 480 days after start of treatment in the immediate-start group.
Time frame: Up to 480 days after start of treatment in the immediate-start group.
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