Actively Recruiting
BIOCHROMADERM® PMCF STUDY
Led by Laboratoires BIOTIC Phocea · Updated on 2025-12-03
115
Participants Needed
3
Research Sites
82 weeks
Total Duration
On this page
Sponsors
L
Laboratoires BIOTIC Phocea
Lead Sponsor
C
Clinical Research Consultants, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
BIOCHROMADERM® PMCF STUDY
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male 18 years or older
- Require 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 participate in the study
You will not qualify if you...
- Known allergy to pigment ingredients
- Active, recent, or prior history of skin disease, chronic skin disease, hypertrophic scars, skin infection, or skin inflammatory disease
- Carrying a prosthesis, especially cardiac
- Presence of a coagulation disorder
- Scheduled for an MRI within 6 months after pigmentation
- Scheduled for skin esthetic treatments (laser, peeling, abrasion) near pigmentation area shortly after pigmentation
- Existing medical conditions or organ pathology near the skin that may pose risk or affect participation
- Pregnant or breastfeeding female
- Currently participating or participated in another clinical trial within 1 month prior
- Personal strong objection to medical tattooing
- Psychiatric illness or social situations limiting consent or compliance
- Under guardianship, curatorship, or other legal protection, or deprived of liberty by judicial or administrative decision
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Centre Oscar Lambret
Lille, France
Not Yet Recruiting
2
Hôpital de La Conception
Marseille, France
Actively Recruiting
3
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
Research Team
M
Marie-Hélène BACHELEY
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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