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

Nordberg Medical AB

Status

Begins enrollment in 5 months

Conditions

Skin Quality

Skin Laxity

Treatments

Device: Poly-L-Lactic Acid (Juläine™)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07332650

NB 15-TF-BZ-100-08F

Details and patient eligibility

About

This study aims to evaluate the efficacy and safety of Juläine™ (poly-L-lactic acid) intradermal injections for the treatment of mild to moderate 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 global 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.

Full description

This is an open-label, multicenter, randomized, parallel-group clinical investigation conducted in Brazil to evaluate the efficacy and safety of Juläine™ (poly-L-lactic acid) administered as intradermal injections for the treatment of mild to moderate skin laxity in the buttock (gluteal) region in adults.

A total of 90 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 last treatment, 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, Global Aesthetic Improvement Scale (GAIS), and BODY-Q 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 treatment initiation, 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults aged 18 to 55 years;
Body Mass Index (BMI) up to 25 kg/m²;
Mild to moderate skin laxity in the gluteal region;
Ability to understand the study and provide informed consent, attend follow-up visits, and follow post-injection instructions.

Exclusion criteria

Pregnancy or breastfeeding, or planned pregnancy/lack of adequate contraception (through 8 weeks post-study);
Active infection/inflammation near the treatment site or acute infection at screening;
Severe/very severe gluteal skin laxity;
Autoimmune disease or immunodeficiency;
History of hypertrophic scarring/keloids or impaired wound healing risk;
Prior buttock surgery or buttock aesthetic procedures within 6 months; planned/ongoing buttock-area aesthetic procedures during the study.
Bleeding disorder/ongoing anticoagulant therapy;
Recent systemic corticosteroids/immunosuppressants (past 2 months) or other collagen-inhibiting agents;
Known hypersensitivity to investigational product components;
Significant dermatologic/systemic disease (e.g., recurrent herpes simplex, skin malignancy);
Planned weight-loss treatment during the study;
Any other medical or psychological condition that, in the investigator's opinion, could interfere with study participation or with the assessment of outcomes.