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

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Skin Aging

Skin Cancer

Treatments

Diagnostic Test: questionnaire of the history of the hair loss

Diagnostic Test: examination of the scalp

Diagnostic Test: questionnaire of clinicals signs

Diagnostic Test: Norwood scale

Procedure: biopsy

Diagnostic Test: blood sample

Diagnostic Test: scinexa score

Diagnostic Test: questionnaire on sun exposure

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03603587

2018-A00714-51 (Other Identifier)

18CH035

Details and patient eligibility

About

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

Full 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

Enrollment

1 patient

Sex

Male

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1 participants in 1 patient group

Patients who will benefit from the removal of a scalp tumour

Experimental group

Description:

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.

Treatment: