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Injectable biostimulators under the microscope: a safety deep dive

NCT ID NCT06993558

Symptom relief Sponsor: Universitätsklinikum Hamburg-Eppendorf 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial investigates the safety and tissue effects of two injectable biostimulators—Poly-L-Lactic Acid (PLLA) and Calcium Hydroxyapatite (CaHA)—used for facial rejuvenation in healthy volunteers aged 30 and older. Participants receive one or two treatment sessions, followed by four check-ups to monitor inflammation, deposit formation, and tissue changes using ultrasound. The goal is to better understand how these treatments interact with facial tissues and their safety profile.

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) or Calcium Hydroxyapatite (CaHA) injections
What this could lead to
If successful, this could confirm the safety of these injectable biostimulators for cosmetic facial rejuvenation.
What could go wrong
This is a small, early-phase study in healthy volunteers, so results may not apply to broader populations or reveal rare side effects.

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 90 people

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

Started

Jul 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Men and women aged 30 years and older Good general health, no relevant pre-existing conditions Patients planning to undergo PLLA or CAHA treatment as part of routine care due to skin laxity or volume loss Cognitive ability and willingness to provide informed consent Willingness and ability to attend follow-up visits -Exclusion Criteria: Age under 30 years Pregnant or breastfeeding individuals Significant open wounds or lesions in the treatment area Metallic implants in the treatment area Psychiatric disorders (psychosis, body dysmorphic disorders) Missing informed consent and/or data privacy declarations

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As listed by the trial registrant

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

This study aims to evaluate the safety profile and tissue changes after biostimulatory treatments to the face in healthy volunteers

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

  • University Hospital Hamburg Eppendorf

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany