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

Primary Purpose

Skin Aging, Skin Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biopsy
blood sample
questionnaire on sun exposure
examination of the scalp
Norwood scale
questionnaire of clinicals signs
scinexa score
questionnaire of the history of the hair loss
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Skin Aging focused on measuring biologic markers, skin cancer, solar aging of skin, alopecic scalp

Eligibility Criteria

65 Years - undefined (Older Adult)MaleDoes not accept 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

Sites / Locations

  • Chu de Saint Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients who will benefit from the removal of a scalp tumour

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Percentage of anisotropy of the tensile forces of the skin
This percentage will be evaluated by silicone casts
histology
Skin aging is evaluated by histological examination: optical and biophotonic microscopy, semi-quantitative measurements of extracellular matrix markers such as collagens and elastin.
Heterogeneity of pigmentation
Heterogeneity of pigmentation will be measured using a numerical index (0 to 100) of heterogeneity, using data from dermatoscopic images.
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.
The measurement of the thickness of the dermis
ultrasound examination: measurement in mm of the thickness of the dermis and the hypodermis
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
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.
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.

Full Information

First Posted
June 7, 2018
Last Updated
March 4, 2020
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Pierre Fabre Dermo Cosmetique
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1. Study Identification

Unique Protocol Identification Number
NCT03603587
Brief Title
Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old.
Acronym
BACCHUS
Official Title
Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old. Mono-centric Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Organisation issues
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Pierre Fabre Dermo Cosmetique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Aging, Skin Cancer
Keywords
biologic markers, skin cancer, solar aging of skin, alopecic scalp

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective mono-centric study of the physiopathology of cutaneous aging.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients who will benefit from the removal of a scalp tumour
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
blood sample
Intervention Description
Blood sample will be collected for performed for HIV serology, B and C hepatitis.
Intervention Type
Diagnostic Test
Intervention Name(s)
questionnaire on sun exposure
Intervention Description
Questionnaire on sun exposure will be completed by patients.
Intervention Type
Diagnostic Test
Intervention Name(s)
examination of the scalp
Intervention Description
A complete examination of the scalp will be completed by dermatologist.
Intervention Type
Diagnostic Test
Intervention Name(s)
Norwood scale
Intervention Description
Norwood scale measure the evolution of baldness. It will be completed by dermatologist.
Intervention Type
Diagnostic Test
Intervention Name(s)
questionnaire of clinicals signs
Intervention Description
Questionnaire of clinicals signs will be completed by dermatologist and patient.
Intervention Type
Diagnostic Test
Intervention Name(s)
scinexa score
Intervention Description
It's a assessment score of skin aging. It will be completed by dermatologist.
Intervention Type
Diagnostic Test
Intervention Name(s)
questionnaire of the history of the hair loss
Intervention Description
Questionnaire of the history of the hair loss will be completed by dermatologist and patient.
Primary Outcome Measure Information:
Title
Scalp skin biomarkers
Description
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.
Time Frame
at the surgery (about 28 days after the inclusion)
Secondary Outcome Measure Information:
Title
Differential expression profile of proteomic biomarkers
Description
The profile will be evaluated by relative quantification results of proteomic analyzes by a Shot-Gun Label-Free strategy.
Time Frame
28 days
Title
Data of thickness measurements of the 3 layers of the skin
Description
Data will be examined by OCT examination (Optical Coherent Tomography): measuring the intensity of the dermis shine and the thickness of the epidermis.
Time Frame
28 days
Title
scalp microflora
Description
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.
Time Frame
28 days
Title
Percentage of anisotropy of the tensile forces of the skin
Description
This percentage will be evaluated by silicone casts
Time Frame
28 days
Title
histology
Description
Skin aging is evaluated by histological examination: optical and biophotonic microscopy, semi-quantitative measurements of extracellular matrix markers such as collagens and elastin.
Time Frame
28 days
Title
Heterogeneity of pigmentation
Description
Heterogeneity of pigmentation will be measured using a numerical index (0 to 100) of heterogeneity, using data from dermatoscopic images.
Time Frame
28 days
Title
Scinexa score (SCore for INtrinsic and EXtrinsic skin Aging)
Description
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.
Time Frame
28 days
Title
The measurement of the thickness of the dermis
Description
ultrasound examination: measurement in mm of the thickness of the dermis and the hypodermis
Time Frame
28 days
Title
The measurement of the morphology of the dermal junction epidermis
Description
examination in MCIV: measurement of the morphology of the dermal junction epidermis by semi-quantitative in vivo confocal microscopy
Time Frame
28 days
Title
Solar exposure score
Description
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.
Time Frame
28 days
Title
Norwood's scale
Description
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.
Time Frame
28 days

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
- Men
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JEAN LUC PERROT, MD
Organizational Affiliation
CHU SAINT ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21146726
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.
Results Reference
background
PubMed Identifier
9358147
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.
Results Reference
background
PubMed Identifier
15675949
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.
Results Reference
background
PubMed Identifier
21454612
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.
Results Reference
background
PubMed Identifier
11238041
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.
Results Reference
background

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

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