AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

BIOCHROMADERM® PMCF STUDY

Recruitingn/aAges 18 Years - anyAllLaboratoires BIOTIC Phocea
💬

In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to: * To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation; * To confirm the continued safety of BIOCHROMADERM®, * To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation * To assess the long-term performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 12 months post-pigmentation (Likert scale) * To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation * To assess fading (pigment retention potential) over 12 months * To assess the number of pigmentation adjustments needed per patient throughout the study duration * To assess patient's satisfaction/self-confidence evolution post-treatment, bot

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Female or male ≥18 years old, * Requiring the reconstruction of the nipple-areola complex following mastectomy, * Affiliated or beneficiary of a social security scheme, * Able and willing to provide written informed consent to study participation. Exclusion Criteria: * Known allergy to pigment ingredients * Active, recent or prior history of skin disease, chronic skin disease, history of hypertrophic scars, skin infection or skin inflammatory disease, * Patients carrying a prosthesis (especially cardiac), * Patients presenting with a coagulation disorder, * Patients scheduled for an MRI within 6 months following pigmentation, * Patients scheduled for a skin esthetic treatment close to the pigmentation zone (laser, peeling, abrasion, ...) shortly after pigmentation, * Existing medical condition or organ pathology close to the skin that the Investigator considers may put the patient at risk or compromise their participation in the study, * Pregnant or breastfeeding female, * Currently participating to another clinical trial or having participated to a prior clinical trial within 1 month prior to inclusion into the present one, * Personal strong objection to medical tattooing, * Psychiatric illness/social situations that would limit ability to consent and/or to compliance with study requirements, * Under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision. Note: The recent use of permanent wrinkle or lip filling products close to the scheduled pigmentation zone (silicon, PTFE, ...) is a contraindication in the approved product IFU but is not relevant to the breast reconstruction indication.
💊

What it tests

  • Not listed
📍

Where

3 sites
Centre Oscar Lambret
Lille, France
Hôpital de La Conception
Marseille, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy