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Can a simple injection tighten loose skin after major weight loss?

NCT ID NCT07637188

Symptom relief Sponsor: Nordberg Medical Italy srl Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether injections of Poly-L-lactic acid (PLLA) can improve skin laxity in people who have loose skin after bariatric surgery. Fifteen participants receive three injections in one thigh over three months, while the other thigh is left untreated. During later plastic surgery, skin samples from both thighs are compared to see if the injections boost collagen and improve skin quality.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Poly-L-lactic acid (PLLA) injections
What this could lead to
If it works, this could offer a non-surgical option to improve skin tightness and quality after major weight loss.
What could go wrong
This is a very early, small proof-of-concept study with only 15 people. It may not show clear benefits, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female aged ≤ 60 years * Previous bariatric surgery (one anastomosis gastric bypass) * Stable weight for at least 6 months prior to baseline * Post-weight loss skin laxity and ptosis requiring surgery * ΔBMI ≥ 7 defined as the change in BMI from scheduled bariatric surgery to baseline * BMI ≤ 30 * Pittsburgh scale rating ≥10 * Ability to give written informed consent * Willing to participate in the study and attending the visits Exclusion Criteria: * Skin infection or skin inflammation status * Acute or chronic skin disease * ΔBMI \< 7 defined as the change in BMI from scheduled bariatric surgery to baseline * BMI \> 30 * Male or female aged 60 \> years * Pregnancy and lactating; if a female is of childbearing potential, she should have a negative pregnancy test and should use a highly effective method to avoid pregnancy for the duration of the trial * Any clinically significant findings, as determined by the investigator, from laboratory tests and individual patient's medical history, that may contraindicate post-bariatric surgery for the patient * History of allergies to any of the constituents of the product * Haemorrhagic disease or under anticoagulant therapy * Have a known history of or susceptibility to keloid formation or hypertrophic scarring * Immune deficiencies

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Conditions

The condition(s) this trial relates to.

cutis laxa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Skin laxity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Senese

    RECRUITING

    Siena, Italy

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