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Recruiting Observational

BIOCHROMADERM® PMCF STUDY

NCT07261904 · tracked via the Priya Life Science France tracker
Sponsor
Laboratoires BIOTIC Phocea
Phase
Observational
Started
2025-11-12
Last updated
2025-12-03

Condition(s) studied

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (3)

FacilityCityRegionStatus
Centre Oscar Lambret Lille France Not Yet Recruiting
Hôpital de La Conception Marseille France Recruiting
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07261904 on ClinicalTrials.gov ↗ ← All trials in France