RecruitingNAINTERVENTIONAL

Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators

This research study is looking into the safety and skin changes that happen after common treatments designed to help your skin look firmer and fuller. We're inviting healthy adults who are planning to have treatments like Sculptra (PLLA), Radiesse or HarmonyCa (Calcium Hydroxyapatite), or radiofrequency microneedling. The aim is to understand how safe these treatments are and exactly what happens to the skin in the treated areas. Participants will receive one of these treatments as part of their routine care and will then have several check-up appointments over two years, where we'll take photos and use ultrasound scans to see the changes. This helps us learn more about these popular treatments.

At a glance

Status

Recruiting

Phase

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

Start

22 Mar 2025

Estimated completion

22 Sep 2026

This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers

What is this study about?

This research study is about understanding how certain popular treatments for your face work and how safe they are. These treatments are designed to help your skin look more youthful by encouraging it to make more of its own natural building blocks. We're focusing on three types: injections like Poly-L-Lactic Acid (also known as Sculptra) and Calcium Hydroxyapatite (like Radiesse or HarmonyCa), and a treatment called Radiofrequency Microneedling. Many people choose these to help with issues like loose skin or loss of fullness in their face.

The main goal is to carefully examine what happens to the skin in the treated area and to make sure these treatments are safe. By taking detailed photos and using special scans called ultrasounds, we can get a clear picture of any changes over time. Your participation would help us gather important information that can improve how these treatments are understood and performed in the future.

Taking part would mean you'd receive one of these treatments, as you might already be planning to do. Afterward, you'd attend several follow-up appointments over two years. These check-ups are important for us to track the effects of the treatment and ensure everything is healing well, which is how we learn the most about how they work.

Key takeaways

Study focuses on safety and tissue changes from face treatments.
Examines Sculptra, Radiesse/HarmonyCa, and Radiofrequency Microneedling.
Participants receive one of these treatments as routine care.
Requires 5 follow-up visits over 2 years for photos and ultrasound.
Aimed at healthy adults 30+ with skin laxity or volume loss.
Helps improve understanding of these popular treatments.

Who may be eligible?

To join this study, you need to be a healthy man or woman aged 30 or older. You should be considering one of the treatments we're studying (Sculptra, Radiesse/HarmonyCa, or radiofrequency microneedling) because you have loose skin or less fullness in your face.

It's important that you are generally in good health and don't have any major existing health problems. You also need to be able to understand the study information and give your permission to take part, and be able to come to all the follow-up appointments.

We can't include you if you are under 30, pregnant, or breastfeeding. Also, if you have open wounds or metal implants in the treatment area, certain mental health conditions, or can't give your clear consent, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 30 years old or older?
Are you generally in good health?
Are you planning to have Sculptra, Radiesse/HarmonyCa, or Radiofrequency Microneedling treatment for your face?
Are you able to attend appointments over the next two years?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive one of the three treatments we are looking at: PLLA (Sculptra), Calcium Hydroxyapatite (Radiesse/HarmonyCa), or Radiofrequency Microneedling. The number of treatment sessions will depend on which option you receive, ranging from a single session for Calcium Hydroxyapatite, to 1-3 sessions for PLLA and Radiofrequency Microneedling, spread out over several weeks. These treatments will follow standard approaches used in clinics.

After your treatment, you will need to attend five follow-up appointments. These will be at 6 weeks, 6 months, 12 months, 18 months, and 24 months after your last treatment. At each visit, we will take photographs and use ultrasound scans to track how your skin is changing. The total duration of your participation, including treatment and follow-ups, will be up to 24 months.

Potential risks and benefits

By taking part, you'll contribute valuable information to better understand the safety and long-term effects of these common facial treatments, which can benefit others in the future. While the treatments themselves are part of routine care and generally considered safe, there are always potential risks with any medical procedure, such as bruising, swelling, or infection, which your doctor will discuss with you. Rest assured, your safety is our top priority, and you are free to change your mind and leave the study at any time without it affecting your medical care.

Locations (1)

University Hospital Hamburg Eppendorf
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What kind of treatments are being studied?

We're looking at treatments like Sculptra, Radiesse, HarmonyCa, and a therapy called Radiofrequency Microneedling, all aimed at improving facial skin.

How many times will I need treatment?

It depends on the treatment you receive. Some might be one session, while others could be 1 to 3 sessions over a few weeks.

What will happen at the follow-up appointments?

At your follow-up visits, we'll take photos and use ultrasound scans to see how your skin is responding to the treatment.

How long will I be in the study?

If you join, your participation will last up to two years, which includes your treatment and all the follow-up appointments.

Who cannot join this study?

You can't join if you're under 30, pregnant, breastfeeding, or have open wounds or metal implants in the treatment area.

How to find out more

Lynhda Nguyen, M.D.

l.nguyen@uke.de +49 40 7410 - 54289 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.