BIOCHROMADERM® PMCF STUDY
Condition(s) studied
Study 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
Eligibility
Primary outcome measure(s)
- 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
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07261904 on ClinicalTrials.gov ↗ ← All trials in France