NCT03603587

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

June 7, 2018

Last Update Submit

March 4, 2020

Conditions

Skin AgingSkin Cancer

Keywords

biologic markersskin cancersolar aging of skinalopecic scalp

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Differential expression profile of proteomic biomarkers

    28 days

  • Data of thickness measurements of the 3 layers of the skin

    28 days

  • scalp microflora

    28 days

  • Percentage of anisotropy of the tensile forces of the skin

    28 days

  • histology

    28 days

  • +6 more secondary outcomes

Study Arms (1)

Patients who will benefit from the removal of a scalp tumour

EXPERIMENTAL

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.

Procedure: biopsyDiagnostic Test: blood sampleDiagnostic Test: questionnaire on sun exposureDiagnostic Test: examination of the scalpDiagnostic Test: Norwood scaleDiagnostic Test: questionnaire of clinicals signsDiagnostic Test: scinexa scoreDiagnostic Test: questionnaire of the history of the hair loss

Interventions

biopsyPROCEDURE

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.

Patients who will benefit from the removal of a scalp tumour
blood sampleDIAGNOSTIC_TEST

Blood sample will be collected for performed for HIV serology, B and C hepatitis.

Patients who will benefit from the removal of a scalp tumour
questionnaire on sun exposureDIAGNOSTIC_TEST

Questionnaire on sun exposure will be completed by patients.

Patients who will benefit from the removal of a scalp tumour
examination of the scalpDIAGNOSTIC_TEST

A complete examination of the scalp will be completed by dermatologist.

Patients who will benefit from the removal of a scalp tumour
Norwood scaleDIAGNOSTIC_TEST

Norwood scale measure the evolution of baldness. It will be completed by dermatologist.

Patients who will benefit from the removal of a scalp tumour
questionnaire of clinicals signsDIAGNOSTIC_TEST

Questionnaire of clinicals signs will be completed by dermatologist and patient.

Patients who will benefit from the removal of a scalp tumour
scinexa scoreDIAGNOSTIC_TEST

It's a assessment score of skin aging. It will be completed by dermatologist.

Patients who will benefit from the removal of a scalp tumour
questionnaire of the history of the hair lossDIAGNOSTIC_TEST

Questionnaire of the history of the hair loss will be completed by dermatologist and patient.

Patients who will benefit from the removal of a scalp tumour

Eligibility Criteria

Age65 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Details\- Men
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Requiring excision of an alopecic scalp lesion
  • from consent signed
  • Patient affiliated or entitled to a social security.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Saint Etienne

Saint-Etienne, 42000, France

Location

Related Publications (5)

  • 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.

    PMID: 21146726BACKGROUND

  • Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available.

    PMID: 9358147BACKGROUND

  • 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.

    PMID: 15675949BACKGROUND

  • 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.

    PMID: 21454612BACKGROUND

  • 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.

    PMID: 11238041BACKGROUND

MeSH Terms

Conditions

Skin Neoplasms

Interventions

BiopsyBlood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesPunctures

Study Officials

  • JEAN LUC PERROT, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a prospective mono-centric study of the physiopathology of cutaneous aging.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2018

First Posted

July 27, 2018

Study Start

February 14, 2019

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)