Skin AgingBACCHUSNCT03603587
Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old.
A study testing biopsy, blood sample and questionnaire on sun exposure in people with Skin Aging and Skin Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Skin Aging, Skin Cancer
- What is being tested?
- biopsy, blood sample and questionnaire on sun exposure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2019to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Requiring excision of an alopecic scalp lesion
- from consent signed
- Patient affiliated or entitled to a social security.
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Skin Aging, Skin Cancer
- Being tested
- biopsy, blood sample, questionnaire on sun exposure, examination of the scalp, Norwood scale
- Keywords
- biologic markers, skin cancer, solar aging of skin, alopecic scalp
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyProcedure or surgery
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.
blood sampleDiagnostic test
Blood sample will be collected for performed for HIV serology, B and C hepatitis.
questionnaire on sun exposureDiagnostic test
Questionnaire on sun exposure will be completed by patients.
examination of the scalpDiagnostic test
A complete examination of the scalp will be completed by dermatologist.
Norwood scaleDiagnostic test
Norwood scale measure the evolution of baldness. It will be completed by dermatologist.
questionnaire of clinicals signsDiagnostic test
Questionnaire of clinicals signs will be completed by dermatologist and patient.
scinexa scoreDiagnostic test
It's a assessment score of skin aging. It will be completed by dermatologist.
questionnaire of the history of the hair lossDiagnostic test
Questionnaire of the history of the hair loss will be completed by dermatologist and patient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: biopsy; Diagnostic Test: blood sample; Diagnostic Test: questionnaire on sun exposure; Diagnostic Test: examination of the scalp; Diagnostic Test: Norwood scale; Diagnostic Test: questionnaire of clinicals signs; Diagnostic Test: scinexa score; Diagnostic Test: questionnaire of the history of the hair loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the surgery (about 28 days after the inclusion)
Secondary outcomes (11)
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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
Percentage of anisotropy of the tensile forces of the skin
This percentage will be evaluated by silicone casts
Measured: 28 days
histology
Skin aging is evaluated by histological examination: optical and biophotonic microscopy, semi-quantitative measurements of extracellular matrix markers such as collagens and elastin.
Measured: 28 days
Heterogeneity of pigmentation
Heterogeneity of pigmentation will be measured using a numerical index (0 to 100) of heterogeneity, using data from dermatoscopic images.
Measured: 28 days
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.
Measured: 28 days
The measurement of the thickness of the dermis
ultrasound examination: measurement in mm of the thickness of the dermis and the hypodermis
Measured: 28 days
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
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start14 Feb 2019
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Why it stopped: Organisation issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective mono-centric study of the physiopathology of cutaneous aging.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre Fabre Dermo Cosmetique
- Responsible party
- Sponsor
- Investigators
- JEAN LUC PERROT, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603587
- Sponsor's protocol ID
- 18CH035
- Other IDs
- 2018-A00714-51
- Acronym
- BACCHUS
- Status last verified
- Mar 2020
- First submitted
- 7 Jun 2018
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21146726Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available.
PubMed 9358147Shin 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.
PubMed 15675949Rock 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.
PubMed 21454612Varani 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.
PubMed 11238041
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old. Mono-centric Prospective Study
- ClinicalTrials.gov ID
- NCT03603587
- Acronym / sponsor ID
- BACCHUS / 18CH035
- Conditions
- Skin Aging, Skin Cancer
- Keywords
- biologic markers, skin cancer, solar aging of skin, alopecic scalp
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Organisation issues
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Pierre Fabre Dermo Cosmetique
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective mono-centric study of the physiopathology of cutaneous aging.
| Arm | Type | Receives |
|---|---|---|
| Patients who will benefit from the removal of a scalp tumour | Experimental | Procedure: biopsy, Diagnostic Test: blood sample, Diagnostic Test: questionnaire on sun exposure, Diagnostic Test: examination of the scalp, Diagnostic Test: Norwood scale, Diagnostic Test: questionnaire of clinicals signs, Diagnostic Test: scinexa score, Diagnostic Test: questionnaire of the history of the hair lossPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Requiring excision of an alopecic scalp lesion
- from consent signed
- Patient affiliated or entitled to a social security.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsyBiopsy 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. | Procedure or surgery | Patients who will benefit from the removal of a scalp tumour |
| blood sampleBlood sample will be collected for performed for HIV serology, B and C hepatitis. | Diagnostic test | Patients who will benefit from the removal of a scalp tumour |
| questionnaire on sun exposureQuestionnaire on sun exposure will be completed by patients. | Diagnostic test | Patients who will benefit from the removal of a scalp tumour |
| examination of the scalpA complete examination of the scalp will be completed by dermatologist. | Diagnostic test | Patients who will benefit from the removal of a scalp tumour |
| Norwood scaleNorwood scale measure the evolution of baldness. It will be completed by dermatologist. | Diagnostic test | Patients who will benefit from the removal of a scalp tumour |
| questionnaire of clinicals signsQuestionnaire of clinicals signs will be completed by dermatologist and patient. | Diagnostic test | Patients who will benefit from the removal of a scalp tumour |
| scinexa scoreIt's a assessment score of skin aging. It will be completed by dermatologist. | Diagnostic test | Patients who will benefit from the removal of a scalp tumour |
| questionnaire of the history of the hair lossQuestionnaire of the history of the hair loss will be completed by dermatologist and patient. | Diagnostic test | Patients who will benefit from the removal of a scalp tumour |
Primary outcome
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.
11 secondary outcomes
Differential expression profile of proteomic biomarkers
Time frame: 28 days
Data of thickness measurements of the 3 layers of the skin
Time frame: 28 days
scalp microflora
Time frame: 28 days
Percentage of anisotropy of the tensile forces of the skin
Time frame: 28 days
histology
Time frame: 28 days
Heterogeneity of pigmentation
Time frame: 28 days
Scinexa score (SCore for INtrinsic and EXtrinsic skin Aging)
Time frame: 28 days
The measurement of the thickness of the dermis
Time frame: 28 days
The measurement of the morphology of the dermal junction epidermis
Time frame: 28 days
Solar exposure score
Time frame: 28 days
Norwood's scale
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Organisation issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Background: PubMed 21146726Zouboulis 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.
- Background: PubMed 9358147Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available.
- Background: PubMed 15675949Shin 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.
- Background: PubMed 21454612Rock 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.
- Background: PubMed 11238041Varani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JEAN LUC PERROT, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy, blood sample and questionnaire on sun exposure in people with Skin Aging and Skin Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Organisation issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scalp skin biomarkers (time frame: at the surgery (about 28 days after the inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03603587, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.