BIOCHROMADERM® PMCF STUDY
Prospective, Observational, Multicentre, Single Group, Open-label Study to Confirm the Safety and Effectiveness of BIOCHROMADERM® Ink for the Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
Laboratoires BIOTIC Phocea
115 participants
Nov 12, 2025
OBSERVATIONAL
Conditions
Summary
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, both in terms of general breast appearance and as to the specific dermo-pigmentation stage * To assess the correlation of the esthetic satisfaction/self-confidence questionnaire outcomes with those of the Likert Scale and patient satisfaction VAS at 3 months and 12 months post-pigmentation
Eligibility
Inclusion Criteria4
- 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 Criteria13
- 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.
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Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07261904