Clinical trial NCT03603587: Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old.
Official title: Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old. Mono-centric Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Skin Aging
Skin Cancer
Keywords: biologic markers
skin cancer
solar aging of skin
alopecic scalp
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Pierre Fabre Dermo Cosmetique
First posted: 2018-07-27
Enrollment: 1
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective mono-centric study of the physiopathology of cutaneous aging.
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Scalp skin biomarkers
timeFrame: at the surgery (about 28 days after the inclusion)
Secondary outcomes:
measure: Differential expression profile of proteomic biomarkers
timeFrame: 28 days
measure: Data of thickness measurements of the 3 layers of the skin
timeFrame: 28 days
measure: scalp microflora
timeFrame: 28 days
measure: Percentage of anisotropy of the tensile forces of the skin
timeFrame: 28 days
measure: histology
timeFrame: 28 days
measure: Heterogeneity of pigmentation
timeFrame: 28 days
measure: Scinexa score (SCore for INtrinsic and EXtrinsic skin Aging)
timeFrame: 28 days
measure: The measurement of the thickness of the dermis
timeFrame: 28 days
measure: The measurement of the morphology of the dermal junction epidermis
timeFrame: 28 days
measure: Solar exposure score
timeFrame: 28 days
measure: Norwood's scale
timeFrame: 28 days
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: JEAN LUC PERROT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available.
citation: 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.
citation: 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.
citation: 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.