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

Not Applicable

Terminated

• Conditions: Skin Cancer; Skin Aging
• Interventions: 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

• Registration Number: NCT03603587
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Study Start: 2019-02-14
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients who will benefit from the removal of a scalp tumour	biopsy	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.
Patients who will benefit from the removal of a scalp tumour	blood sample	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.
Patients who will benefit from the removal of a scalp tumour	scinexa score	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.
Patients who will benefit from the removal of a scalp tumour	questionnaire on sun exposure	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.
Patients who will benefit from the removal of a scalp tumour	questionnaire of clinicals signs	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.
Patients who will benefit from the removal of a scalp tumour	questionnaire of the history of the hair loss	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.
Patients who will benefit from the removal of a scalp tumour	examination of the scalp	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.
Patients who will benefit from the removal of a scalp tumour	Norwood scale	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.

Primary Outcome Measures

Name	Time	Method
Scalp skin biomarkers	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.

Secondary Outcome Measures

Name	Time	Method
Data of thickness measurements of the 3 layers of the skin	28 days	Data will be examined by OCT examination (Optical Coherent Tomography): measuring the intensity of the dermis shine and the thickness of the epidermis.
scalp microflora	28 days	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.
Differential expression profile of proteomic biomarkers	28 days	The profile will be evaluated by relative quantification results of proteomic analyzes by a Shot-Gun Label-Free strategy.
The measurement of the thickness of the dermis	28 days	ultrasound examination: measurement in mm of the thickness of the dermis and the hypodermis
The measurement of the morphology of the dermal junction epidermis	28 days	examination in MCIV: measurement of the morphology of the dermal junction epidermis by semi-quantitative in vivo confocal microscopy
Solar exposure score	28 days	Solar exposure score : to assess in different periods; 1. period of 10 to 17 years old; 2. period of 18 to 40 years old; 3. period of 41 to 60 years old; 4. 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.
Norwood's scale	28 days	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.
Percentage of anisotropy of the tensile forces of the skin	28 days	This percentage will be evaluated by silicone casts
histology	28 days	Skin aging is evaluated by histological examination: optical and biophotonic microscopy, semi-quantitative measurements of extracellular matrix markers such as collagens and elastin.
Heterogeneity of pigmentation	28 days	Heterogeneity of pigmentation will be measured using a numerical index (0 to 100) of heterogeneity, using data from dermatoscopic images.
Scinexa score (SCore for INtrinsic and EXtrinsic skin Aging)	28 days	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.

Trial Locations

Locations (1)

Chu de Saint Etienne; 🇫🇷 Saint Etienne, France