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

March 4, 2020 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Etienne, France, 42000
        • CHU de Saint Étienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients who will benefit from the removal of a scalp tumour

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: 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.
Diagnostic test: questionnaire on sun exposure
Questionnaire on sun exposure will be completed by patients.
Diagnostic test: examination of the scalp
A complete examination of the scalp will be completed by dermatologist.
Diagnostic test: Norwood scale
Norwood scale measure the evolution of baldness. It will be completed by dermatologist.
Diagnostic test: questionnaire of clinicals signs
Questionnaire of clinicals signs will be completed by dermatologist and patient.
Diagnostic test: scinexa score
It's a assessment score of skin aging. It will be completed by dermatologist.
Diagnostic test: questionnaire of the history of the hair loss
Questionnaire of the history of the hair loss will be completed by dermatologist and patient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Scalp skin biomarkers
Time Frame: at the surgery (about 28 days after the inclusion)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differential expression profile of proteomic biomarkers
Time Frame: 28 days
The profile will be evaluated by relative quantification results of proteomic analyzes by a Shot-Gun Label-Free strategy.
28 days
Data of thickness measurements of the 3 layers of the skin
Time Frame: 28 days
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
scalp microflora
Time Frame: 28 days
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
Percentage of anisotropy of the tensile forces of the skin
Time Frame: 28 days
This percentage will be evaluated by silicone casts
28 days
histology
Time Frame: 28 days
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
Heterogeneity of pigmentation
Time Frame: 28 days
Heterogeneity of pigmentation will be measured using a numerical index (0 to 100) of heterogeneity, using data from dermatoscopic images.
28 days
Scinexa score (SCore for INtrinsic and EXtrinsic skin Aging)
Time Frame: 28 days

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
The measurement of the thickness of the dermis
Time Frame: 28 days
ultrasound examination: measurement in mm of the thickness of the dermis and the hypodermis
28 days
The measurement of the morphology of the dermal junction epidermis
Time Frame: 28 days
examination in MCIV: measurement of the morphology of the dermal junction epidermis by semi-quantitative in vivo confocal microscopy
28 days
Solar exposure score
Time Frame: 28 days

Solar exposure score : to assess in different periods

  1. period of 10 to 17 years old
  2. period of 18 to 40 years old
  3. period of 41 to 60 years old
  4. 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
Norwood's scale
Time Frame: 28 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pierre Fabre Dermo Cosmetique

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JEAN LUC PERROT, MD, CHU Saint Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18CH035
  • 2018-A00714-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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