DermatoporosisNCT05699980
Prevalence and Comorbidities of Dermatoporosis: a French Prospective Observational Study in General Medicine Consultation
An observational study of Dermatoporosis, run by University of Lorraine at 15 sites in France.
Trial summary
The term dermatoporosis (DP) was proposed by JH. Saurat in 2004 and detailed in 2007 to describe a chronic cutaneous insufficiency and fragility syndrome. The concept of DP, the positive diagnosis and the complications are well identified in the literature. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatoporosis
- How many people
- 370 participants
- Where
- 15 sitesFrance
- Study dates
- 23 May 2022to 3 Oct 2022
- Phase
- Observational
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients aged 60 or over presenting to their general practitioner.
Who may be able to join
- Patient presenting to his general practitioner
- Patient aged 60 or over
Who cannot join
- Refusal of participation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Stéphanie Chevalier
Ancerville, 55170
Wissam Al Shouaib
Basse-Ham, 57970
Sophie LARUELLE
Bénaménil, 54450
Sophie Delaporte
Bulgnéville, 88140
Cédric Berbé
Cattenom, 57570
Sandra Pacini
Hayange, 57700
Anais Leclerc
Hettange-Grande, 57330
Benoit Nicolas
Hettange-Grande, 57330
Mathieu Zimmermann
Le Val-dAjol, 88340
Mélanie Damervalle
Longuyon, 54260
Patrick Vauthier
Longwy, 54400
Aurelie François
Raon-l'Étape, 88110
Jean-Louis Autissier
Thaon-les-Vosges, 88150
Cabinet Tronville en Barrois
Tronville-en-Barrois, 55310
Cabinet Varangéville
Varangéville, 54110
About this study
The term dermatoporosis (DP) was proposed by JH. Saurat in 2004 and detailed in 2007 to describe a chronic cutaneous insufficiency and fragility syndrome.
The concept of DP, the positive diagnosis and the complications are well identified in the literature. However, while the consequences of skin aging are a growing concern, knowledge of DP is stagnant.
Read more
DP is clinically defined by the combination of three clinical signs: skin atrophy, white pseudo-scars, and senile purpura. It mainly sits on photo-exposed regions: posterior face of the forearms and back of the hands in 92 to 100% of cases; but also the pre-tibial, pre-sternal, and cephalic regions.
DP appears at around 60 years old and can worsen with advancing age. Complications of varying severity can occur during its development: skin tears, delayed healing, infection, hematomas including dissecting hematomas that are sometimes life-threatening.
DP is classified into four stages defined in 2004 and revised in 2012. The autonomy of the DP entity or its integration as a marker in multi-organ failure has not yet been determined. It is a condition on the borders of several specialties requiring good coordination between them (dermatologists, general practitioners, geriatricians, nurses, etc.)
The few published epidemiological studies report a prevalence ranging from 4% to 37.5% in patients aged 50 years and over. These epidemiological data are very heterogeneous (age of recruitment, patients hospitalized or seen on an outpatient basis in consultations of different specialties, sample of the population, etc.).
Among these studies, three clinical studies, two on a French hospital cohort, the other on outpatients in Dermatology in Finland, estimated the prevalence of DP between 27 and 32% in adults aged 60 years and older. In all three studies, DP was associated with advanced age, with a risk of DP up to double in patients aged 85 and older compared to younger patients. In two of these studies, a link was suggested with the status of chronic renal failure, either independently for one, or concomitant with taking anticoagulants and corticosteroids for the other. For Kluger et al., DP was also associated with the independent use of very strong local or systemic corticosteroids. For Chanca et al., an independent link between DP and tobacco consumption, taking anticoagulant treatment, and chronic recreational sun exposure has been observed.
Read the detailed description
No clinical study has evaluated the prevalence of DP and the comorbidities often cited in adults aged 60 and over in general practice consultations.
The primary objective of this study is to assess the prevalence in a population aged 60 and over followed in a general practice in the North East of France (Lorraine). In addition, as it has been shown an association between DP and comorbidities or drug intake, the secondary objective is to investigate the possible existence of such associations.
Study design:
An observational, descriptive, transversal, multicenter study was conducted in the North East of France (Lorraine) between May and October 2022. We included by half-day, consecutively, all patients aged 60 and over presenting to a general medical consultation with 20 volunteer practitioners from the 4 Lorraine departments. Each practitioner was trained in the diagnosis of DP through a 27-minutes E-learning video and phone contacts.
Clinical and biological variables:
For each patient, the general practitioner performed his usual clinical examination, with a dermatological examination of the upper limbs. He completed an anonymous online questionnaire with data collected from the interrogation, medical files, and clinical examination.
The following data were reported: demographic data, active or former smoking, diabetes, dermatological history (atopic dermatitis, bullous dermatosis, psoriasis), chronic renal failure (MDRD < 60ml /min/m2), past sun exposure, Fitzpatrick phototype, treatments (anticoagulant, antiplatelet, systemic, local, inhaled corticosteroid therapy (cumulative duration >= 1 month)).
Finally, the signs of DP and the stage were filled in. For this study, we used the clinical staging of DP as proposed by Kaya and Saurat in 2012.
When signs of DP were present, photos of the dorsal aspect of the forearms and back of the hands (usual practice) were reviewed by the investigator and a dermatologist to confirm the diagnosis. The questionnaires were analyzed by the principal investigator.
As Chanca et al., we divided past sun exposure into three types: recreational, occupational, and childhood exposure. To assess chronic recreational sun exposure, patients were asked about past outdoor activities, such as walking or cycling at least 2 times/week. Occupational sun exposure was defined based on whether patients had an indoor or outdoor occupation. Childhood sun exposure was defined by a history of childhood sunburn.
Fitzpatrick phototype distinguishes six skin types based on tone, from very light skin that never tans (phototype 1), to dark skin, which never gets sunburn (phototype 6). According to this classification, we divided the patients into two categories: light skin (phototypes 1 to 3) and dark skin (phototypes 4 to 6).
- Conditions
- Dermatoporosis
- Keywords
- skin ageing, sun exposure, skin tears, purpura
- Medical subject headings
- Purpura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient aged 60 or over presenting to their general practitioner | Patient aged 60 or over presenting to his general practitioner (among the 20 general practitioners recruited in Lorraine (eastern France)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of dermatoporosis on the forearms or back of the hands
Presence or absence of dermatoporosis on the forearms or back of the hands in patients aged 60 or over in general practice
Measured: At admission, Day 1
Secondary outcomes (11)
Measurement of phototype
Measurement of phototype as a risk factor for dermatoporosis
Measured: At admission, Day 1
Childhood sun exposure
Childhood sun exposure as a risk factor for dermatoporosis
Measured: At admission, Day 1
Lifetime sun exposure Measurement of phototype
Lifetime sun exposure as a risk factor for dermatoporosis
Measured: At admission, Day 1
Tobacco consumption
Tobacco consumption as a risk factor for dermatoporosis
Measured: At admission, Day 1
Presence or absence of diabetes
Diabetes as a risk factor for dermatoporosis
Measured: At admission, Day 1
Presence or absence of chronic renal failure
chronic renal failure as a risk factor for dermatoporosis
Measured: At admission, Day 1
Presence or absence of antiplatelet consumption
antiplatelet consumption as a risk factor for dermatoporosis
Measured: At admission, Day 1
Presence or absence of anticoagulant consumption
anticoagulant consumption as a risk factor for dermatoporosis
Measured: At admission, Day 1
Presence or absence of systemic corticosteroid therapy
systemic corticosteroid therapy as a risk factor for dermatoporosis
Measured: At admission, Day 1
Presence or absence of topical corticosteroid
topical corticosteroid on the forearms or back of the hands as a risk factor for dermatoporosis
Measured: At admission, Day 1
Presence or absence of inhaled corticosteroid
inhaled corticosteroid as a risk factor for dermatoporosis
Measured: At admission, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start23 May 2022
- Primary completion23 May 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DermatoporosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lorraine
- Sponsor type
- University, hospital or other
- Collaborators
- Study Director: Anne Claire Bursztejn, PHD-MD, CHU Nancy - University of Lorraine, Study Chair: Christophe Goetz, MD, CHR Metz-Thionville - University of Lorraine
- Responsible party
- Principal investigator, Antoine Truchetet, University of Lorraine
- Investigators
- Antoine Truchetet, MD, Principal investigator, University of LorraineAnne Claire Bursztejn, PHD-MD, Study director, CHU Nancy - University of LorraineCédric Berbé, MD, Study director, University of LorraineChristophe Goetz, MD, Study chair, CHR Metz-Thionville - University of Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699980
- Sponsor's protocol ID
- University of Lorraine
- Status last verified
- Apr 2023
- First submitted
- 17 Jan 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaya G, Saurat JH. Dermatoporosis: a chronic cutaneous insufficiency/fragility syndrome. Clinicopathological features, mechanisms, prevention and potential treatments. Dermatology. 2007;215(4):284-94. doi: 10.1159/000107621.
PubMed 17911985Mengeaud V, Dautezac-Vieu C, Josse G, Vellas B, Schmitt AM. Prevalence of dermatoporosis in elderly French hospital in-patients: a cross-sectional study. Br J Dermatol. 2012 Feb;166(2):442-3. doi: 10.1111/j.1365-2133.2011.10534.x. Epub 2011 Dec 5. No abstract available.
PubMed 21787367Chanca L, Fontaine J, Kerever S, Feneche Y, Forasassi C, Meaume S, Colboc H. Prevalence and risk factors of dermatoporosis in older adults in a rehabilitation hospital. J Am Geriatr Soc. 2022 Apr;70(4):1252-1256. doi: 10.1111/jgs.17618. Epub 2021 Dec 17.
PubMed 34918778Kluger N, Impivaara S. Prevalence of and risk factors for dermatoporosis: a prospective observational study of dermatology outpatients in a Finnish tertiary care hospital. J Eur Acad Dermatol Venereol. 2019 Feb;33(2):447-450. doi: 10.1111/jdv.15240. Epub 2018 Oct 1.
PubMed 30198583
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Comorbidities of Dermatoporosis: a French Prospective Observational Study in General Medicine Consultation
- ClinicalTrials.gov ID
- NCT05699980
- Acronym / sponsor ID
- University of Lorraine
- Conditions
- Dermatoporosis
- Keywords
- skin ageing, sun exposure, skin tears, purpura
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- University of LorraineUniversity, hospital or other
- Collaborators
- Study Director: Anne Claire Bursztejn, PHD-MD, CHU Nancy - University of Lorraine, Study Chair: Christophe Goetz, MD, CHR Metz-Thionville - University of Lorraine
- Study start
- 23 May 2022 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 26 Jan 2023 (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 term dermatoporosis (DP) was proposed by JH. Saurat in 2004 and detailed in 2007 to describe a chronic cutaneous insufficiency and fragility syndrome.
The concept of DP, the positive diagnosis and the complications are well identified in the literature. However, while the consequences of skin aging are a growing concern, knowledge of DP is stagnant.
DP is clinically defined by the combination of three clinical signs: skin atrophy, white pseudo-scars, and senile purpura. It mainly sits on photo-exposed regions: posterior face of the forearms and back of the hands in 92 to 100% of cases; but also the pre-tibial, pre-sternal, and cephalic regions.
DP appears at around 60 years old and can worsen with advancing age. Complications of varying severity can occur during its development: skin tears, delayed healing, infection, hematomas including dissecting hematomas that are sometimes life-threatening.
DP is classified into four stages defined in 2004 and revised in 2012. The autonomy of the DP entity or its integration as a marker in multi-organ failure has not yet been determined. It is a condition on the borders of several specialties requiring good coordination between them (dermatologists, general practitioners, geriatricians, nurses, etc.)
The few published epidemiological studies report a prevalence ranging from 4% to 37.5% in patients aged 50 years and over. These epidemiological data are very heterogeneous (age of recruitment, patients hospitalized or seen on an outpatient basis in consultations of different specialties, sample of the population, etc.).
Among these studies, three clinical studies, two on a French hospital cohort, the other on outpatients in Dermatology in Finland, estimated the prevalence of DP between 27 and 32% in adults aged 60 years and older. In all three studies, DP was associated with advanced age, with a risk of DP up to double in patients aged 85 and older compared to younger patients. In two of these studies, a link was suggested with the status of chronic renal failure, either independently for one, or concomitant with taking anticoagulants and corticosteroids for the other. For Kluger et al., DP was also associated with the independent use of very strong local or systemic corticosteroids. For Chanca et al., an independent link between DP and tobacco consumption, taking anticoagulant treatment, and chronic recreational sun exposure has been observed.
Detailed description
No clinical study has evaluated the prevalence of DP and the comorbidities often cited in adults aged 60 and over in general practice consultations.
The primary objective of this study is to assess the prevalence in a population aged 60 and over followed in a general practice in the North East of France (Lorraine). In addition, as it has been shown an association between DP and comorbidities or drug intake, the secondary objective is to investigate the possible existence of such associations.
Study design:
An observational, descriptive, transversal, multicenter study was conducted in the North East of France (Lorraine) between May and October 2022. We included by half-day, consecutively, all patients aged 60 and over presenting to a general medical consultation with 20 volunteer practitioners from the 4 Lorraine departments. Each practitioner was trained in the diagnosis of DP through a 27-minutes E-learning video and phone contacts.
Clinical and biological variables:
For each patient, the general practitioner performed his usual clinical examination, with a dermatological examination of the upper limbs. He completed an anonymous online questionnaire with data collected from the interrogation, medical files, and clinical examination.
The following data were reported: demographic data, active or former smoking, diabetes, dermatological history (atopic dermatitis, bullous dermatosis, psoriasis), chronic renal failure (MDRD < 60ml /min/m2), past sun exposure, Fitzpatrick phototype, treatments (anticoagulant, antiplatelet, systemic, local, inhaled corticosteroid therapy (cumulative duration >= 1 month)).
Finally, the signs of DP and the stage were filled in. For this study, we used the clinical staging of DP as proposed by Kaya and Saurat in 2012.
When signs of DP were present, photos of the dorsal aspect of the forearms and back of the hands (usual practice) were reviewed by the investigator and a dermatologist to confirm the diagnosis. The questionnaires were analyzed by the principal investigator.
As Chanca et al., we divided past sun exposure into three types: recreational, occupational, and childhood exposure. To assess chronic recreational sun exposure, patients were asked about past outdoor activities, such as walking or cycling at least 2 times/week. Occupational sun exposure was defined based on whether patients had an indoor or outdoor occupation. Childhood sun exposure was defined by a history of childhood sunburn.
Fitzpatrick phototype distinguishes six skin types based on tone, from very light skin that never tans (phototype 1), to dark skin, which never gets sunburn (phototype 6). According to this classification, we divided the patients into two categories: light skin (phototypes 1 to 3) and dark skin (phototypes 4 to 6).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient aged 60 or over presenting to their general practitioner | – | –Patient aged 60 or over presenting to his general practitioner (among the 20 general practitioners recruited in Lorraine (eastern France)) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 60 or over presenting to their general practitioner.
Key inclusion criteria (2 listed)
- Patient presenting to his general practitioner
- Patient aged 60 or over
Key exclusion criteria (1 listed)
- Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of dermatoporosis on the forearms or back of the hands
Time frame: At admission, Day 1
Presence or absence of dermatoporosis on the forearms or back of the hands in patients aged 60 or over in general practice
11 secondary outcomes
Measurement of phototype
Time frame: At admission, Day 1
Childhood sun exposure
Time frame: At admission, Day 1
Lifetime sun exposure Measurement of phototype
Time frame: At admission, Day 1
Tobacco consumption
Time frame: At admission, Day 1
Presence or absence of diabetes
Time frame: At admission, Day 1
Presence or absence of chronic renal failure
Time frame: At admission, Day 1
Presence or absence of antiplatelet consumption
Time frame: At admission, Day 1
Presence or absence of anticoagulant consumption
Time frame: At admission, Day 1
Presence or absence of systemic corticosteroid therapy
Time frame: At admission, Day 1
Presence or absence of topical corticosteroid
Time frame: At admission, Day 1
Presence or absence of inhaled corticosteroid
Time frame: At admission, Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Background: PubMed 17911985Kaya G, Saurat JH. Dermatoporosis: a chronic cutaneous insufficiency/fragility syndrome. Clinicopathological features, mechanisms, prevention and potential treatments. Dermatology. 2007;215(4):284-94. doi: 10.1159/000107621.
- Background: PubMed 21787367Mengeaud V, Dautezac-Vieu C, Josse G, Vellas B, Schmitt AM. Prevalence of dermatoporosis in elderly French hospital in-patients: a cross-sectional study. Br J Dermatol. 2012 Feb;166(2):442-3. doi: 10.1111/j.1365-2133.2011.10534.x. Epub 2011 Dec 5. No abstract available.
- Background: PubMed 34918778Chanca L, Fontaine J, Kerever S, Feneche Y, Forasassi C, Meaume S, Colboc H. Prevalence and risk factors of dermatoporosis in older adults in a rehabilitation hospital. J Am Geriatr Soc. 2022 Apr;70(4):1252-1256. doi: 10.1111/jgs.17618. Epub 2021 Dec 17.
- Background: PubMed 30198583Kluger N, Impivaara S. Prevalence of and risk factors for dermatoporosis: a prospective observational study of dermatology outpatients in a Finnish tertiary care hospital. J Eur Acad Dermatol Venereol. 2019 Feb;33(2):447-450. doi: 10.1111/jdv.15240. Epub 2018 Oct 1.
- Individual participant dataSharing planned: No
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.
Antoine Truchetet, MD principal investigator
University of Lorraine
Anne Claire Bursztejn, PHD-MD study director
CHU Nancy - University of Lorraine
Cédric Berbé, MD study director
University of Lorraine
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatoporosis, run by University of Lorraine at 15 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence or absence of dermatoporosis on the forearms or back of the hands (time frame: At admission, Day 1). 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 NCT05699980, which also lists 4 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 1 May 2023.