BIOCHROMADERM® PMCF STUDY

NCT07261904 | Recruiting

• 1 other identifier: ID-RCB 2024-A01845-42
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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,
• 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.

Sponsors & Collaborators

• Laboratoires BIOTIC Phocea: lead
• Clinical Research Consultants, Inc.: collaborator

Study Sites (3)

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

Central Study Contacts

Marie-Hélène BACHELEY

CONTACT

+33785453676; regulatory@biotic.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): June 12, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)