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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A00714-51 | Other Identifier | ANSM |
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Organisation issues
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| Name | Class |
|---|---|
| Pierre Fabre Dermo Cosmetique | INDUSTRY |
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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
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who will benefit from the removal of a scalp tumour | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biopsy | Procedure | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Men
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| Name | Affiliation | Role |
|---|---|---|
| JEAN LUC PERROT, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Saint Etienne | Saint-Etienne | 42000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21146726 | Background | Zouboulis CC, Makrantonaki E. Clinical aspects and molecular diagnostics of skin aging. Clin Dermatol. 2011 Jan-Feb;29(1):3-14. doi: 10.1016/j.clindermatol.2010.07.001. | |
| 9358147 | Background | Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available. |
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This is a prospective mono-centric study of the physiopathology of cutaneous aging.
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| blood sample | Diagnostic Test | Blood sample will be collected for performed for HIV serology, B and C hepatitis. |
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| questionnaire on sun exposure | Diagnostic Test | Questionnaire on sun exposure will be completed by patients. |
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| examination of the scalp | Diagnostic Test | A complete examination of the scalp will be completed by dermatologist. |
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| Norwood scale | Diagnostic Test | Norwood scale measure the evolution of baldness. It will be completed by dermatologist. |
|
| questionnaire of clinicals signs | Diagnostic Test | Questionnaire of clinicals signs will be completed by dermatologist and patient. |
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| scinexa score | Diagnostic Test | It's a assessment score of skin aging. It will be completed by dermatologist. |
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| questionnaire of the history of the hair loss | Diagnostic Test | Questionnaire of the history of the hair loss will be completed by dermatologist and patient. |
|
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
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 |
| 15675949 | Background | Shin MH, Rhie GE, Park CH, Kim KH, Cho KH, Eun HC, Chung JH. Modulation of collagen metabolism by the topical application of dehydroepiandrosterone to human skin. J Invest Dermatol. 2005 Feb;124(2):315-23. doi: 10.1111/j.0022-202X.2004.23588.x. |
| 21454612 | Background | Rock K, Grandoch M, Majora M, Krutmann J, Fischer JW. Collagen fragments inhibit hyaluronan synthesis in skin fibroblasts in response to ultraviolet B (UVB): new insights into mechanisms of matrix remodeling. J Biol Chem. 2011 May 20;286(20):18268-76. doi: 10.1074/jbc.M110.201665. Epub 2011 Mar 17. |
| 11238041 | Background | Varani J, Spearman D, Perone P, Fligiel SE, Datta SC, Wang ZQ, Shao Y, Kang S, Fisher GJ, Voorhees JJ. Inhibition of type I procollagen synthesis by damaged collagen in photoaged skin and by collagenase-degraded collagen in vitro. Am J Pathol. 2001 Mar;158(3):931-42. doi: 10.1016/S0002-9440(10)64040-0. |
| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D011677 | Punctures |
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