BIOCHROMADERM® for nipple-areola complex repigmentation after mastectomy
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
This study will test BIOCHROMADERM® pigment implants to restore a near-normal nipple-areola color for adults having nipple reconstruction after mastectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 115 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laboratoires BIOTIC Phocea Industry-sponsored |
| Locations | 3 sites (Lille and 2 other locations) |
| Trial ID | NCT07261904 on ClinicalTrials.gov |
What this trial studies
This is an observational post‑market follow-up of patients who receive BIOCHROMADERM® pigmentation as part of nipple-areola complex reconstruction after mastectomy. Investigators will record pigmentary appearance using Likert scales at baseline, 3 months and 12 months, track pigment fading and the number of pigmentation touch-ups, and monitor safety and usability of the implantation process. Patient satisfaction and self-confidence related to breast appearance will be measured over the study period. The study excludes patients with pigment ingredient allergies, active skin disease, certain implants or coagulation disorders, and those who are pregnant or planning MRI soon after pigmentation.
Who should consider this trial
Good fit: Adults (≥18 years) needing nipple-areola reconstruction after mastectomy who can give informed consent and are eligible per inclusion/exclusion criteria are ideal candidates.
Not a fit: Patients with known allergy to the pigment, active or chronic skin disease, coagulation disorders, certain implanted prostheses, pregnancy/breastfeeding, or those planning MRI or nearby skin treatments soon after pigmentation may not benefit.
Why it matters
Potential benefit: If successful, the product could provide durable, near-normal nipple-areola pigmentation and improve patients' satisfaction and self-confidence after reconstruction.
How similar studies have performed: Dermopigmentation and micropigmentation techniques have been used successfully for nipple-areola reconstruction, but implantable BIOCHROMADERM® has limited long-term published data and this PMCF aims to confirm its continuing performance.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lille and 2 other locations
- 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)
Study contacts
- Study coordinator: Marie-Hélène BACHELEY
- Email: regulatory@biotic.fr
- Phone: +33785453676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.