RecruitingOBSERVATIONAL

BIOCHROMADERM® PMCF STUDY

This study is about a product called BIOCHROMADERM®, used to help rebuild the nipple and the darker skin around it (areola) for people who have had breast removal surgery (mastectomy). The main aim is to see how well BIOCHROMADERM® helps create a natural look over 3 months, and then up to a year. We're also checking that it's safe to use and understanding the best way to apply it. The study will look at how happy patients are with their new appearance and how their self-confidence changes after treatment. Your feedback will help doctors understand if this treatment is a good option for others in the future.

At a glance

Status

Recruiting

Sponsor

Laboratoires BIOTIC Phocea

Enrolment target

115

Start

12 Nov 2025

Estimated completion

12 Jun 2027

Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy

What is this study about?

When someone has a mastectomy, which is surgery to remove a breast, they might also choose to have their breast rebuilt. Part of this rebuilding can involve creating a new nipple and the darker area around it, called the areola. This study is looking at a specific treatment called BIOCHROMADERM®, which helps to create this natural-looking colour.

We want to understand several things: Does BIOCHROMADERM® help the reconstructed nipple and areola look natural at 3 months and then at 12 months after the treatment? Is it safe to use? We also want to learn the best way to apply it and how long it lasts without fading. It's really important to know if patients are happy with the results and if it helps them feel more confident about their appearance.

By carefully observing how BIOCHROMADERM® performs, we hope to improve how doctors care for patients after breast surgery. Your participation would help us gather important information to make sure this treatment is effective, safe, and makes a positive difference to people's lives.

Key takeaways

This study looks at how well BIOCHROMADERM® works to create a natural-looking nipple and areola.
It aims to confirm the safety of the treatment.
It checks how happy patients are with their appearance and confidence.
Participation lasts about 12 months, with a few check-up visits.
You can leave the study whenever you want to.

Who may be eligible?

This study is for adults aged 18 or over. It's specifically for people, whether male or female, who need to have their nipple and the darker skin around it (areola) rebuilt after having breast removal surgery (mastectomy).

There are certain reasons why someone wouldn't be able to join. For example, if you have allergies to any of the ingredients in BIOCHROMADERM®, have certain skin conditions, or are pregnant or breastfeeding. We also can't include people who have major heart devices, bleeding disorders, or who are having certain other medical procedures or treatments around the same time.

You also need to be able to understand what the study involves and be willing to give written permission to take part. It's important that you don't have strong feelings against medical tattooing or any mental health conditions that would make it difficult for you to understand and follow the study instructions.

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 18 years old or older?
Do you need to have your nipple and areola rebuilt after breast surgery?
Do you have any known allergies to tattoo pigments?
Are you currently pregnant or breastfeeding?
Are you comfortable with the idea of 'medical tattooing'?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new medication, as this is an observational study. This means doctors will be watching how the BIOCHROMADERM® treatment works for you as part of your standard care. You will have the BIOCHROMADERM® applied, and then attend follow-up visits. During these visits, doctors will check how your reconstructed nipple and areola look, how well the colour has stayed, and record your satisfaction with the results. You will be asked questions about your feelings and confidence. They'll also note if any top-up treatments are needed to adjust the colour.

These check-ups will usually happen at certain times after your treatment, including at 3 months and then again at 12 months. The total duration of your involvement in the study would be about 12 months from when you have the BIOCHROMADERM® applied.

Potential risks and benefits

Taking part in this study could offer you the benefit of close monitoring of your breast reconstruction, ensuring your doctors are carefully observing how well the BIOCHROMADERM® works for you. Your feedback is very valuable and will help other patients in the future. Potential risks are generally linked to the BIOCHROMADERM® application itself, such as potential mild discomfort or temporary redness, similar to having a tattoo. The study will carefully monitor for any unexpected reactions. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Centre Oscar Lambret
Verified postcode
Lille, France· Not yet recruiting
Hôpital de La Conception
Verified postcode
Marseille, France· Recruiting
Institut de Cancérologie de Lorraine
Verified postcode
Vandœuvre-lès-Nancy, France· Not yet recruiting

Common questions

What is BIOCHROMADERM®?

BIOCHROMADERM® is a product used to create natural-looking colour for a new nipple and areola (the darker skin around it) after breast removal surgery.

Is this a new treatment?

This study is observing how BIOCHROMADERM® performs, confirming its safety and effectiveness in a real-world setting, rather than testing a brand new treatment for the first time.

Will I have to pay to take part?

No, you will not have to pay to participate in this study. It's designed to observe a treatment that's part of your care.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, and this decision will not affect your medical care.

How long will I be involved?

Your involvement in the study will typically last for about 12 months, with follow-up visits at 3 months and 12 months after the treatment.

How to find out more

Marie-Hélène BACHELEY

regulatory@biotic.fr +33785453676 Official trial record

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