BIOCHROMADERM® PMCF STUDY

Recruiting now

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

In brief

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

Key facts

Study ID: NCT07261904
Run by: Laboratoires BIOTIC Phocea
People needed: 115
Starts: 2025-11-12
Expected to finish: 2027-06-12
Last updated by the study team: 2025-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Hôpital de La Conception — Marseille, France (enrolling)
Centre Oscar Lambret — Lille, France
Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France

Full record on ClinicalTrials.gov

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