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NCT07261904
BIOCHROMADERM® PMCF STUDY
trial in Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy in 115 participants. Currently enrolling.
12 October 2026
Quick facts
| Lead sponsor | Laboratoires BIOTIC Phocea |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 115 |
| Start date | 12 November 2025 |
| Primary completion | 12 October 2026 |
| Estimated completion | 12 June 2027 |
| Sites | 3 locations across France |
Conditions studied
- Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy — all drugs for Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy →
Sponsor
Laboratoires BIOTIC Phocea
Who can join
18 and older, any sex, with Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07261904 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Laboratoires BIOTIC Phocea
- Last refreshed: 3 December 2025
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing