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临床试验/NCT03603587
NCT03603587终止不适用

Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old. Mono-centric Prospective Study

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
Scalp skin biomarkers

研究概览

简要总结

The aging of skin, especially that of the scalp, is a combination of intrinsic and extrinsic aging factors secondary to the chronic sun exposure. For men with an alopecia genetic (= bald men), the solar part, in skin aging process, is major.

The helio-dermal scalp is frequently the site of cancers mainly after 65 years. Objectives are to identify specific biomarkers involved in the photo-aging of the alopecic scalp

详细描述

Investigators can also hope to understand and to explain the inter-individual inequality of the aging of skin. They can hope to a better understanding of the biological mechanisms between photo-induced skin aging and photo-induced carcinogenesis.

Investigators propose to study 40 male patients aged 65 and over in order to compare the state of aging of their scalp skin in the alopecic zone :

not hairy photo-exposed (= ZH sun damage zone) versus occipital hair zone protected photo (= ZT control zone).

Patients will be recruited in the dermatology department of the St-Etienne University Hospital who will benefit from the removal of a scalp tumour in the alopecic zone.

This study aims to identify biological markers, by transcriptomic analysis, associated with aging of the scalp, by comparing for each patient the skin of the scalp exposed to the light ("ZH") to an unexposed witness skin ("ZT").

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Requiring excision of an alopecic scalp lesion
  • from consent signed
  • Patient affiliated or entitled to a social security.

排除标准

  • scalp infection
  • inflammatory disease of the scalp
  • genetic disease with even partial expression of the scalp
  • medical treatment of scalp less than 3 weeks old
  • antecedent radiotherapy of the cephalic extremity
  • prior surgery of the scalp with regard to the area sampled
  • Application of hair implants, or any other surgical or medical procedures of the scalp
  • Washing of the scalp or application of a cosmetic product for less than 48 hours
  • Artificial hair coloring.
  • any contraindication to surgical excision

结局指标

主要结局

Scalp skin biomarkers

时间窗: at the surgery (about 28 days after the inclusion)

Comparison of scalp skin biomarkers. It's compare cell differentiation, cell proliferation, cellular pigmentation, cell adhesion, cytoskeleton, aging and cellular senescence, extracellular matrix, antioxidant activity and inflammation.

次要结局

  • Data of thickness measurements of the 3 layers of the skin(28 days)
  • scalp microflora(28 days)
  • Differential expression profile of proteomic biomarkers(28 days)
  • The measurement of the thickness of the dermis(28 days)
  • The measurement of the morphology of the dermal junction epidermis(28 days)
  • Solar exposure score(28 days)
  • Norwood's scale(28 days)
  • Percentage of anisotropy of the tensile forces of the skin(28 days)
  • histology(28 days)
  • Heterogeneity of pigmentation(28 days)
  • Scinexa score (SCore for INtrinsic and EXtrinsic skin Aging)(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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