临床试验/NCT07261904

NCT07261904招募中不适用

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

Laboratoires BIOTIC Phocea3 个研究点分布在 1 个国家目标入组 115 人开始时间: 2025年11月12日最近更新: 2025年12月3日

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 115
试验地点: 3
主要终点: To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Observational
观察模型: Other
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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,
•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.

结局指标

主要结局

To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation

时间窗: 3 months post-pigmentation

次要结局

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)
To assess the number of pigmentation adjustments needed per patient throughout the study duration(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(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(12 months)

研究者

发起方

Laboratoires BIOTIC Phocea

申办方类型

Industry

责任方

Sponsor

研究点 (3)

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