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

Skin Cancer Clinical Trial

— BACCHUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03603587
• Other study ID #: 18CH035
• Secondary ID: 2018-A00714-51
• Status: Terminated
• Phase: N/A
• Start date: February 14, 2019
• Est. completion date: September 20, 2019

Study information

• Verified date: March 2020
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Aging
• Skin Cancer
• Skin Neoplasms

Intervention

Procedure:
• 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.

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	Chu de Saint Etienne	Saint Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Pierre Fabre Dermo Cosmetique

Country where clinical trial is conducted

France, 

References & Publications (5)

Röck 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. — View 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. — View Citation

Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Percentage of anisotropy of the tensile forces of the skin	This percentage will be evaluated by silicone casts	28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	The measurement of the thickness of the dermis	ultrasound examination: measurement in mm of the thickness of the dermis and the hypodermis	28 days
Secondary	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
Secondary	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
Secondary	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