Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following MastectomyNCT07261904
BIOCHROMADERM® PMCF STUDY
An observational study of Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy, run by Laboratoires BIOTIC Phocea at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
- How many people
- 115 participants
- Where
- 3 sitesFrance
- Study dates
- 12 Nov 2025to 12 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 13Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Centre Oscar Lambret
Lille
Claudia Regis, Doctor
- Recruiting
Hôpital de La Conception
Marseille
Dominique Casanova, Professor
- Not yet recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Laetitia Goffinet, Doctor
About this study
Official title: 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
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation
Measured: 3 months post-pigmentation
Secondary outcomes (8)
To confirm the continued safety of BIOCHROMADERM®
Measured: 12 months
To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation
Measured: 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)
Measured: 12 months
To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation
Measured: 12 months
To assess fading (pigment retention potential) over 12 months
Measured: 12 months
To assess the number of pigmentation adjustments needed per patient throughout the study duration
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start12 Nov 2025
- Primary completion12 Oct 2026 (estimated)
- Study completion12 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires BIOTIC Phocea
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Consultants, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261904
- Sponsor's protocol ID
- ID-RCB 2024-A01845-42
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07261904
- Acronym / sponsor ID
- ID-RCB 2024-A01845-42
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Laboratoires BIOTIC PhoceaIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Consultants, Inc.
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 12 Jun 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation
Time frame: 3 months post-pigmentation
8 secondary outcomes
To confirm the continued safety of BIOCHROMADERM®
Time frame: 12 months
To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation
Time frame: 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)
Time frame: 12 months
To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation
Time frame: 12 months
To assess fading (pigment retention potential) over 12 months
Time frame: 12 months
To assess the number of pigmentation adjustments needed per patient throughout the study duration
Time frame: 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
Time frame: 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
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy, run by Laboratoires BIOTIC Phocea at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Hélène BACHELEY (+33785453676, regulatory@biotic.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation (time frame: 3 months post-pigmentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.