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.
Adults aged 18 to 55 years;
Body Mass Index (BMI) between 18.5 and 24.95 kg/m².
Skin laxity of the gluteal region defined as sagging and reduced tightness of the skin.
Women of childbearing potential must be willing to abide by the contraceptive requirements
Pregnancy or breastfeeding, or planned pregnancy/lack of adequate contraception (through 8 weeks post-study);
Is planning to donate/bank or retrieve eggs (ova, oocytes) or donate sperm during the study or within 8-weeks of the end of participation of the clinical investigation.
Active infection, inflammation or lesions at or near the treatment site.
Acute infection at screening;
Parallel
Poly-L-Lactic Acid (Juläine™)
DeviceJuläine™ 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.
Mean change in overall skin elasticity
Mean change in global medial skin elasticity measured by cutometer 180 days after treatment completion.
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.
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.
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.
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