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

NCT07332650 | Not Yet Recruiting

• 1 other identifier: NB 15-TF-BZ-100-08F
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Skin Quality; Skin Laxity

Keywords

Poly-L-lactic acid; PLLA; Aesthetic; Injectable filler; Buttocks; Gluteal skin laxity; Buttock skin laxity; Skin elasticity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 240 days after randomization

Secondary Outcomes (7)

• Mean change in overall skin elasticity

  Baseline and Day 240 after randomization.

• Global improvement based on Global Aesthetic Improvement Scale (GAIS) evaluated by investigator

  Baseline and Day 240 after randomization.

• Global improvement based on Global Aesthetic Improvement Scale (GAIS) evaluated by participant

  Baseline and Day 240 after randomization.

• Proportion of adverse events (AEs)

  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

  First 30 days after each Juläine™ administration, in all treated participants.

Study Arms (2)

Immediate-treatment group

EXPERIMENTAL

Device: Poly-L-Lactic Acid (Juläine™)

Delayed-treatment group (delayed-start control)

OTHER

Device: Poly-L-Lactic Acid (Juläine™)

Interventions

Poly-L-Lactic Acid (Juläine™) DEVICE

Juläine™ is a sterile injectable medical device composed of polylactic acid microspheres.

Delayed-treatment group (delayed-start control); Immediate-treatment group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Ability to understand the study and provide informed consent, attend follow-up visits, and follow post-injection instructions.

You may not qualify if:

• 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;
• History of autoimmune disease;
• Immune deficiencies;
• History of hypertrophic scarring or keloid formation;
• Previous surgical procedures involving the buttocks
• Aesthetic procedure on the buttocks (including fillers, elevation wires, radiofrequency, ultrasound, cryotherapy, fat injection, neurotoxin, laser or light treatment, or chemical peel) within 6 months prior to randomization.
• Hemorrhagic disease or ongoing use of antiplatelets/anticoagulant therapy.
• Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (inhaled or ophthalmic corticosteroids are allowed).
• Use of hormonal replacement therapy (HRT) unless the participant has been on a stable dose for at least 3 months prior to screening and does not plan to make any changes to the HRT regimen during the study period.
• Use of topical corticosteroids, topical prescription retinoids in the treatment area within 1 month of the Baseline visit or systemic retinoid treatment within 6 months of the baseline visit, or plan to receive such treatment.
• Use of other agents that inhibit collagen production.
• Known allergy or hypersensitivity to any component of the investigational product.

Sponsors & Collaborators

• Nordberg Medical AB: lead

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03