Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:53 AM
Study NCT ID:
NCT07332650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2025-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Juläine™ in Improving Gluteal Skin Laxity in Adults.
Sponsor:
Nordberg Medical AB
Organization:
Study Overview
Official Title:
A Pivotal, Open-Label, Two-Arm, Randomized, Parallel-Group, Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Juläine™ in Improving Gluteal Skin Laxity in Adults.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: