Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old.

Study Overview
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Brief Summary
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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

Detailed Description
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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). The study will include : examinations to characterize components of the scalp: transcriptomic, proteomic and immunohistochemical analysis of skin biopsies, and a swab sampling will identify the cutaneous microflora of the scalp noninvasive examinations, in vivo

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

Conditions
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Skin Aging, Skin Cancer

Intervention / Treatment
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* Procedure: biopsy
* Diagnostic Test: blood sample
* Diagnostic Test: questionnaire on sun exposure
* Diagnostic Test: examination of the scalp
* Diagnostic Test: Norwood scale
* Diagnostic Test: questionnaire of clinicals signs
* Diagnostic Test: scinexa score
* Diagnostic Test: questionnaire of the history of the hair loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requiring excision of an alopecic scalp lesion from consent signed Patient affiliated or entitled to a social security. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective mono-centric study of the physiopathology of cutaneous aging.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients who will benefit from the removal of a scalp tumour<br>Patients who will benefit from the removal of a scalp tumour in the alopecic zone will be recruited in the dermatology department of the St-Etienne University Hospital. They will have biopsy, blood sample, examination of the scalp, questionnaire on sun exposure, Norwood scale, scinexa score, questionnaire of clinicals signs and questionnaire of the history of the hair loss. | Procedure: biopsy<br>* Biopsy 4 to 5 mm from the distal part of the tips of the excision pieces. Three biopsies of 3 mm, made with punch, occipital hair zone (ZT) A completely painless sample, using a swab (soaked with a buffer solution) on the scalp of the ZH and ZT zone.<br>Diagnostic Test: blood sample<br>* Blood sample will be collected for performed for HIV serology, B and C hepatitis.<br>Diagnostic Test: questionnaire on sun exposure<br>* Questionnaire on sun exposure will be completed by patients.<br>Diagnostic Test: examination of the scalp<br>* A complete examination of the scalp will be completed by dermatologist.<br>Diagnostic Test: Norwood scale<br>* Norwood scale measure the evolution of baldness. It will be completed by dermatologist.<br>Diagnostic Test: questionnaire of clinicals signs<br>* Questionnaire of clinicals signs will be completed by dermatologist and patient.<br>Diagnostic Test: scinexa score<br>* It's a assessment score of skin aging. It will be completed by dermatologist.<br>Diagnostic Test: questionnaire of the history of the hair loss<br>* Questionnaire of the history of the hair loss will be completed by dermatologist and patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scalp skin biomarkers | 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. | at the surgery (about 28 days after the inclusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential expression profile of proteomic biomarkers | The profile will be evaluated by relative quantification results of proteomic analyzes by a Shot-Gun Label-Free strategy. | 28 days | 
| Data of thickness measurements of the 3 layers of the skin | Data will be examined by OCT examination (Optical Coherent Tomography): measuring the intensity of the dermis shine and the thickness of the epidermis. | 28 days | 
| scalp microflora | Microflora will be evaluated by high-throughput sequencing (Illumina MiSeq) of the V1-V3 region of the ribosomal RNA (bacteria) and Internal Transcribed Spacer 1 (eukaryotes: yeasts) and evaluation of the amount of P. acnes of the scalp by quantitative RT-PCR of the lipase A gene. | 28 days | 
| Percentage of anisotropy of the tensile forces of the skin | This percentage will be evaluated by silicone casts | 28 days | 
| histology | Skin aging is evaluated by histological examination: optical and biophotonic microscopy, semi-quantitative measurements of extracellular matrix markers such as collagens and elastin. | 28 days | 
| Heterogeneity of pigmentation | Heterogeneity of pigmentation will be measured using a numerical index (0 to 100) of heterogeneity, using data from dermatoscopic images. | 28 days | 
| Scinexa score (SCore for INtrinsic and EXtrinsic skin Aging) | The aging of the skin is evaluated by a semi-quantitative composite of 23 clinical variables : the scinexa score The global SCINEXA score (from 0 to 69. 0 = no skin aging and 69 = severe skin aging ) was obtained by adding the scores of each variable from 0 to 3. 0 = none, 1 = mild, 2 = moderate and 3 = severe. | 28 days | 
| The measurement of the thickness of the dermis | ultrasound examination: measurement in mm of the thickness of the dermis and the hypodermis | 28 days | 
| The measurement of the morphology of the dermal junction epidermis | examination in MCIV: measurement of the morphology of the dermal junction epidermis by semi-quantitative in vivo confocal microscopy | 28 days | 
| Solar exposure score | Solar exposure score : to assess in different periods period of 10 to 17 years old period of 18 to 40 years old period of 41 to 60 years old period since 61 years old Each period contains same questions. Each item being rated in 5 answer choice from 1 to 5 (never, rarely, sometimes, often or very often) and two questions concern the zone where the patient live. | 28 days | 
| Norwood's scale | The Norwood Scale is a set of images that depict the different stages of male pattern hair loss. The Norwood scale is composed of 12 images. Each image corresponds to one level. There is 7 levels (I , II, II A, III, III vertex, III A, IV, IVA, V, VA, VI, VII) Type I. Minimal hair loss. Type VII. The most severe form of hair loss. Little hair on the front or top of the head. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biologic markers, skin cancer, solar aging of skin, alopecic scalp