Skin QualityNCT07332650

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

A study testing Poly-L-Lactic Acid (Juläine™) in people with Skin Quality and Skin Laxity, run by Nordberg Medical AB.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Skin Quality, Skin Laxity
What is being tested?: Poly-L-Lactic Acid (Juläine™)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: Oct 2026to Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 21Show fewer

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.
History of herpes simplex rashes, malignant skin diseases, or any other serious dermatologic or systemic disease.
Presence of any condition that may impair wound healing (e.g., connective tissue disorders, severe malnutrition).
Planned or ongoing cosmetic procedures involving the buttocks or surrounding area during the period of clinical investigation.
Extensive tattoos covering >50% of the total gluteal area.
Participants actively taking GLP-1 medications with the intention of achieving additional weight loss (expected >10% during study) will be excluded. Participants on a stable GLP-1 regimen (≥3 months) for diabetes management or weight maintenance, with documented weight stability (±10% in past 6 months) and no planned or expected weight change >10%, may be included.
Any other medical or psychological condition that, in the opinion of the investigator, may interfere with participation in clinical research or evaluation of results.

About this study

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.

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.

Read the 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.

Conditions: Skin Quality, Skin Laxity
Being tested: Poly-L-Lactic Acid (Juläine™)
Keywords: Poly-L-lactic acid, PLLA, Aesthetic, Injectable filler, Buttocks, Gluteal skin laxity, Buttock skin laxity, Skin elasticity
Medical subject headings: Cutis Laxa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Poly-L-Lactic Acid (Juläine™)Device
Juläine™ is a sterile injectable medical device composed of polylactic acid microspheres.

Study groups in NCT07332650
Study group	Role	What they receive
Immediate-treatment group	Experimental	Not described Receives: Device: Poly-L-Lactic Acid (Juläine™)
Delayed-treatment group (delayed-start control)	Other	Not described Receives: Device: Poly-L-Lactic Acid (Juläine™)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 240 days after randomization

Secondary outcomes (7)

Mean change in overall skin elasticity
Mean change in global medial skin elasticity measured by cutometer 180 days after treatment completion.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 480 days after start of treatment in the immediate-start group.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2026Jun 2027

First posted12 Jan 2026
Study startOct 2026 (estimated)
Primary completionApr 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Skin QualityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07332650
Sponsor's protocol ID: NB 15-TF-BZ-100-08F
Status last verified: Mar 2026
First submitted: 30 Dec 2025
Last updated: 19 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Skin Quality trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT07332650
Acronym / sponsor ID: NB 15-TF-BZ-100-08F
Conditions: Skin Quality, Skin Laxity
Keywords: Poly-L-lactic acid, PLLA, Aesthetic, Injectable filler, Buttocks, Gluteal skin laxity, Buttock skin laxity, Skin elasticity
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Nordberg Medical ABIndustry (pharma, biotech, devices)
Study start: Oct 2026 (estimated)
Primary completion: Apr 2027 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 12 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aims to evaluate the safety and effectiveness of Juläine™ (poly-L-lactic acid) injections for the treatment of buttock skin laxity.

This multicenter trial will be conducted in Brazil.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate-treatment group	Experimental	Device: Poly-L-Lactic Acid (Juläine™)
Delayed-treatment group (delayed-start control)	Other	Device: Poly-L-Lactic Acid (Juläine™)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (21 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Poly-L-Lactic Acid (Juläine™)Juläine™ is a sterile injectable medical device composed of polylactic acid microspheres.	Device	Delayed-treatment group (delayed-start control), Immediate-treatment group

Primary outcome

Proportion of participants who achieve an improvement in gluteal skin elasticity
Time frame: Baseline and 240 days after randomization
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.

7 secondary outcomes

Mean change in overall skin elasticity
Time frame: Baseline and Day 240 after randomization.
Global improvement based on Global Aesthetic Improvement Scale (GAIS) evaluated by investigator
Time frame: Baseline and Day 240 after randomization.
Global improvement based on Global Aesthetic Improvement Scale (GAIS) evaluated by participant
Time frame: Baseline and Day 240 after randomization.
Proportion of adverse events (AEs)
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
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.
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
Time frame: Up to 480 days after start of treatment in the immediate-start group.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Poly-L-Lactic Acid (Juläine™) in people with Skin Quality and Skin Laxity, run by Nordberg Medical AB.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who achieve an improvement in gluteal skin elasticity (time frame: Baseline and 240 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07332650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.