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

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

Study Overview

• Status: Recruiting
• Conditions: Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy

• Study Type: Observational
• Enrollment (Estimated): 115

Contacts and Locations

• Study Contact: Name: Marie-Hélène BACHELEY; Phone Number: +33785453676; Email: regulatory@biotic.fr

Study Locations

• France
  • Lille, France
    • Not yet recruiting
    • Centre Oscar Lambret
    • Principal Investigator: Claudia Regis, Doctor
  • Marseille, France
    • Recruiting
    • Hôpital de la Conception
    • Principal Investigator: Dominique Casanova, Professor
  • Vandœuvre-lès-Nancy, France
    • Not yet recruiting
    • Institut de Cancerologie de Lorraine
    • Principal Investigator: Laetitia Goffinet, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients requiring the correction of skin pigmentation in the NAC area as a result of breast reconstructive surgery following mastectomy.

Up to 115 patients will be included into the study by 3 clinical sites, in order to obtain 103 treated patients followed up over 12 months post-procedure per protocol

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation	3 months post-pigmentation

Secondary Outcome Measures

Outcome Measure	Time Frame
To confirm the continued safety of BIOCHROMADERM®	12 months
To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation	12 months
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)	12 months
To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation	12 months
To assess fading (pigment retention potential) over 12 months	12 months
To assess the number of pigmentation adjustments needed per patient throughout the study duration	12 months
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	12 months
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	12 months

Collaborators and Investigators

• Sponsor: Laboratoires BIOTIC Phocea
• Collaborators: Clinical Research Consultants, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2025
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): June 12, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 29, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 29, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ID-RCB 2024-A01845-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No