DermatoporosisDermatoporoseNCT05092204
Prevalence and Risk Factors of Dermatoporosis in Patients Over 75 Years of Age Hospitalized in Reeducation
An observational study of Dermatoporosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The term dermatoporosis, by analogy to osteoporosis, was proposed by Professor Saurat to define all the manifestations linked to skin aging leading to fragility and skin failure. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Dermatoporosis
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2021to 15 May 2021
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized patient in SSR over 75 years old.
Who may be able to join
- Hospitalized patient in SSR
- Over 75 years old patient
Who cannot join
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
The term dermatoporosis, by analogy to osteoporosis, was proposed by Professor Saurat to define all the manifestations linked to skin aging leading to fragility and skin failure. With age, the gradual disappearance of hyaluronic acid and its CD44 cell receptor leads to the degeneration of the extracellular matrix and then to the loss of the protective mechanical functions of the skin. It thus appears an alteration of the viscoelasticity of the skin. The most common skin manifestations of dermatoporosis are mainly located on the upper limbs. Several clinical manifestations characterize dermatoporosis: skin atrophy, senile purpura, stellate pseudo-scars, delayed healing and finally dissecting skin hematoma. There are 4 evolutionary stages of dermatoporosis described by Professor Saurat and by Doctor Kaya, in 2007: Stage 1: strong thinning of the skin with senile purpura and stellate pseudo-scars. Stage 2: manifestations of the previous stage and small, localized skin lacerations resulting from a cleavage between the dermis and the epidermis. Stage 3: more and larger skin lacerations with a noticeable delay in healing Stage 4: the progression of the lesions described above leads to the formation of dissecting skin hematomas which may progress to skin necrosis. (Saurat JH Dermatoporosis - the functional side of skin aging. Dermatology 2007 and Kaya G, dermatoporosis: A chronic cutaneous insufficiency / fragility syndrome. Clinicopathological features, mechanisms, prevention and potential treatments. Dermatology 2007).
A study by Mengeaud et al found a significant association between severe renal failure and dermatoporosis. Two studies, one in Toulouse and the other in Finland, looked at the prevalence and risk factors of dermatoporosis in patients over 60 years of age. The observational study on 202 patients over 60 years old in Toulouse shows a prevalence of 32%, with preferentially localization on the upper limbs. Stage 1 is the most common. Multivariate statistical analyzes show that dermatoporosis is significantly associated with the use of local and oral corticosteroids, anticoagulants, and chronic renal failure. On the other hand, it has not been shown to be associated with diabetes and the patient's sun exposure.Another study, dating from 2018 also found that kidney failure, taking antiaggregants and anticoagulants, corticosteroid therapy (local or systemic) are risk factors for dermatoporosis. However, no study has been carried out on a geriatric population, and the association between phototype, sun exposure and dermatoporosis has to our knowledge never been systematically investigated in the few studies conducted.
Read the detailed description
This study will allow us to know the prevalence and the risk factors of dermatoporosis in a poorly understood geriatric population. No study on the subject in patients over 75 years in the literature. We will be interested in collecting on the observations of patients recorded in Orbis (Initial medical assessment and evolution), in particular if the patient has chronic renal failure, is diabetic, has anticoagulants, antiaggregants or corticosteroids as a background treatment.
Main objective To assess the prevalence of dermatoporosis in patients over 75 years of age hospitalized in reeducation. Secondary objectives: Investigate risk factors for dermatoporosis - Evaluate the prevalence of complications of dermatoporosis
- Conditions
- Dermatoporosis
- Keywords
- Skin aging, Dermatoporosis
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 |
|---|---|---|
| Hospitalized patient in SSR geriatric service | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of dermatoporosis
Presence or absence of dermatoporosis in geriatric patients hospitalized in the CRH
Measured: From admission to discharge, up to 1 month
Secondary outcomes (4)
Measurement of phototype
Measurement of phototype as a risk factors for dermatoporosis
Measured: At admission, Day 1
Childhood sun exposure Measurement of phototype
Childhood sun exposure as a risk factors for dermatoporosis
Measured: At admission, Day 1
Lifetime sun exposure Measurement of phototype
Lifetime sun exposure as a risk factors for dermatoporosis
Measured: At admission, Day 1
Complications of dermatoporosis:
Complications of dermatoporosis: dissecting hematoma, skin tear on clinical examination and in history
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 posted25 Oct 2021
- Study start29 Mar 2021
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatoporosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hester COLBOC, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092204
- Sponsor's protocol ID
- APHP210431
- Acronym
- Dermatoporose
- Status last verified
- Oct 2021
- First submitted
- 14 May 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Dermatoporosis in Patients Over 75 Years of Age Hospitalized in Reeducation
- ClinicalTrials.gov ID
- NCT05092204
- Acronym / sponsor ID
- Dermatoporose / APHP210431
- Conditions
- Dermatoporosis
- Keywords
- Skin aging, Dermatoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 25 Oct 2021 (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, by analogy to osteoporosis, was proposed by Professor Saurat to define all the manifestations linked to skin aging leading to fragility and skin failure. With age, the gradual disappearance of hyaluronic acid and its CD44 cell receptor leads to the degeneration of the extracellular matrix and then to the loss of the protective mechanical functions of the skin. It thus appears an alteration of the viscoelasticity of the skin. The most common skin manifestations of dermatoporosis are mainly located on the upper limbs. Several clinical manifestations characterize dermatoporosis: skin atrophy, senile purpura, stellate pseudo-scars, delayed healing and finally dissecting skin hematoma. There are 4 evolutionary stages of dermatoporosis described by Professor Saurat and by Doctor Kaya, in 2007: Stage 1: strong thinning of the skin with senile purpura and stellate pseudo-scars. Stage 2: manifestations of the previous stage and small, localized skin lacerations resulting from a cleavage between the dermis and the epidermis. Stage 3: more and larger skin lacerations with a noticeable delay in healing Stage 4: the progression of the lesions described above leads to the formation of dissecting skin hematomas which may progress to skin necrosis. (Saurat JH Dermatoporosis - the functional side of skin aging. Dermatology 2007 and Kaya G, dermatoporosis: A chronic cutaneous insufficiency / fragility syndrome. Clinicopathological features, mechanisms, prevention and potential treatments. Dermatology 2007).
A study by Mengeaud et al found a significant association between severe renal failure and dermatoporosis. Two studies, one in Toulouse and the other in Finland, looked at the prevalence and risk factors of dermatoporosis in patients over 60 years of age. The observational study on 202 patients over 60 years old in Toulouse shows a prevalence of 32%, with preferentially localization on the upper limbs. Stage 1 is the most common. Multivariate statistical analyzes show that dermatoporosis is significantly associated with the use of local and oral corticosteroids, anticoagulants, and chronic renal failure. On the other hand, it has not been shown to be associated with diabetes and the patient's sun exposure.Another study, dating from 2018 also found that kidney failure, taking antiaggregants and anticoagulants, corticosteroid therapy (local or systemic) are risk factors for dermatoporosis. However, no study has been carried out on a geriatric population, and the association between phototype, sun exposure and dermatoporosis has to our knowledge never been systematically investigated in the few studies conducted.
Detailed description
This study will allow us to know the prevalence and the risk factors of dermatoporosis in a poorly understood geriatric population. No study on the subject in patients over 75 years in the literature. We will be interested in collecting on the observations of patients recorded in Orbis (Initial medical assessment and evolution), in particular if the patient has chronic renal failure, is diabetic, has anticoagulants, antiaggregants or corticosteroids as a background treatment.
Main objective To assess the prevalence of dermatoporosis in patients over 75 years of age hospitalized in reeducation. Secondary objectives: Investigate risk factors for dermatoporosis - Evaluate the prevalence of complications of dermatoporosis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patient in SSR geriatric service | – | – |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized patient in SSR over 75 years old.
Key inclusion criteria (2 listed)
- Hospitalized patient in SSR
- Over 75 years old patient
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
Time frame: From admission to discharge, up to 1 month
Presence or absence of dermatoporosis in geriatric patients hospitalized in the CRH
4 secondary outcomes
Measurement of phototype
Time frame: At admission, Day 1
Childhood sun exposure Measurement of phototype
Time frame: At admission, Day 1
Lifetime sun exposure Measurement of phototype
Time frame: At admission, Day 1
Complications of dermatoporosis:
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 27 Sep 2022.
- Individual participant dataSharing planned: Undecided
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.
Hester COLBOC principal investigator
Assistance Publique - Hôpitaux de Paris
1 site 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 Assistance Publique - Hôpitaux de Paris 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 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 27 Sep 2022. 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 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 (time frame: From admission to discharge, up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2022.