Clinical Trials Directory

Trials / Terminated

TerminatedNCT03603587

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

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
1 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
Male
Age
65 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREbiopsyBiopsy 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_TESTblood sampleBlood sample will be collected for performed for HIV serology, B and C hepatitis.
DIAGNOSTIC_TESTquestionnaire on sun exposureQuestionnaire on sun exposure will be completed by patients.
DIAGNOSTIC_TESTexamination of the scalpA complete examination of the scalp will be completed by dermatologist.
DIAGNOSTIC_TESTNorwood scaleNorwood scale measure the evolution of baldness. It will be completed by dermatologist.
DIAGNOSTIC_TESTquestionnaire of clinicals signsQuestionnaire of clinicals signs will be completed by dermatologist and patient.
DIAGNOSTIC_TESTscinexa scoreIt's a assessment score of skin aging. It will be completed by dermatologist.
DIAGNOSTIC_TESTquestionnaire of the history of the hair lossQuestionnaire of the history of the hair loss will be completed by dermatologist and patient.

Timeline

Start date
2019-02-14
Primary completion
2019-09-20
Completion
2019-09-20
First posted
2018-07-27
Last updated
2020-03-05

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03603587. Inclusion in this directory is not an endorsement.