Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old.
NCT ID: NCT03603587
Last Updated: 2020-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2019-02-14
2019-09-20
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients who will benefit from the removal of a scalp tumour
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.
biopsy
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.
blood sample
Blood sample will be collected for performed for HIV serology, B and C hepatitis.
questionnaire on sun exposure
Questionnaire on sun exposure will be completed by patients.
examination of the scalp
A complete examination of the scalp will be completed by dermatologist.
Norwood scale
Norwood scale measure the evolution of baldness. It will be completed by dermatologist.
questionnaire of clinicals signs
Questionnaire of clinicals signs will be completed by dermatologist and patient.
scinexa score
It's a assessment score of skin aging. It will be completed by dermatologist.
questionnaire of the history of the hair loss
Questionnaire of the history of the hair loss will be completed by dermatologist and patient.
Interventions
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biopsy
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.
blood sample
Blood sample will be collected for performed for HIV serology, B and C hepatitis.
questionnaire on sun exposure
Questionnaire on sun exposure will be completed by patients.
examination of the scalp
A complete examination of the scalp will be completed by dermatologist.
Norwood scale
Norwood scale measure the evolution of baldness. It will be completed by dermatologist.
questionnaire of clinicals signs
Questionnaire of clinicals signs will be completed by dermatologist and patient.
scinexa score
It's a assessment score of skin aging. It will be completed by dermatologist.
questionnaire of the history of the hair loss
Questionnaire of the history of the hair loss will be completed by dermatologist and patient.
Eligibility Criteria
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Inclusion Criteria
* from consent signed
* Patient affiliated or entitled to a social security.
Exclusion Criteria
* 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
65 Years
MALE
No
Sponsors
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Pierre Fabre Dermo Cosmetique
INDUSTRY
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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JEAN LUC PERROT, MD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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Chu de Saint Etienne
Saint-Etienne, , France
Countries
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References
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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.
Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available.
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.
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.
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.
Other Identifiers
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2018-A00714-51
Identifier Type: OTHER
Identifier Source: secondary_id
18CH035
Identifier Type: -
Identifier Source: org_study_id
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