Senile PurpuraFAWDNCT05037604
Factors Associated With Dermatoporosis
An observational study of Senile Purpura, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
Dermatoporosis is a chronic syndrome of skin insufficiency or fragility. It is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. Dermatoporosis prevalence is 37% in ≥65 years. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Senile Purpura
- What is being tested?
- Questionnaire about associated factors, Self questionnaire diagnostic tool and Physical Examination
- Type of treatment
- Pill or oral medicine
- How many people
- 315 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2018to 30 Apr 2019
- 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: Patients over 60 years of age who attended the outpatient clinic of the Hospital Central "Dr. Ignacio Morones Prieto "
Who may be able to join
- Patients over 60 years
Who cannot join
- Patients in whom physical examination cannot be performed due to the use of orthopedic devices such as splints, bandages, etc.
- Patients with whom interviewer-patient verbal communication is difficult due to some hearing or neurological deficit.
- Patients with neurological, psychiatric disorders who are unable to provide reliable information. (disorganized, incoherent speech, cognitive deficit)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, 78220
About this study
Dermatoporosis is a chronic syndrome of skin insufficiency or fragility. It is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. Dermatoporosis prevalence is 37% in ≥65 years.
The objective was to determine factors associated with this diagnosis in >60 years old patients of the outpatient clinic in the Hospital Central "Dr. Ignacio Morones Prieto " San Luis Potosí, México.
An observational, cross-sectional, descriptive, and analytical study was performed. Patients >60 years old were selected. A clinical history, clinical examination, and application of a validated diagnostic self-questionnaire were performed.
Read the detailed description
Dermatoporosis is a chronic syndrome of skin insufficiency or fragility. It is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. Dermatoporosis prevalence is 37% in ≥65 years.The objective was to determine factors associated with this diagnosis in >60 years old patients of the outpatient clinic in the Hospital Central "Dr. Ignacio Morones Prieto " San Luis Potosí, México.
An observational, cross-sectional, descriptive and analytical study was performed. Through consecutive non-probabilistic sampling, patients > 60 years old were selected, who underwent a clinical history, clinical examination, and the application of a validated diagnostic self-questionnaire. To determine the association of the factors, a multivariate logistic regression analysis, it will be used the PRIMERv6 software with the PERMANOVA package. A p <0.05 was considered significant. The normality of the distribution of the continuous variables was evaluated with the Shapiro Wilk test. The Student's t test was performed on variables that met the homogeneity of variance requirements. In the variables that did not meet this criterion, a non-parametric analysis was performed with the Mann U Whitney test. For the analysis of categorical variables, Fisher's exact test or chi-square test was used. Continuous variables were reported by mean (median) [Q1, Q3] (min - max) and by standard deviations as their distribution corresponds. Nominal categorical variables were expressed as frequencies
- Conditions
- Senile Purpura
- Being tested
- Questionnaire about associated factors, Self questionnaire diagnostic tool, Physical Examination
- Keywords
- dermatoporosis, senile, purpura
- Medical subject headings
- Purpura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire about associated factorsOther
Questionnaire about age, prolonged sun exposure, intake of anticoagulants / antiplatelets, intake of oral steroids, chronic kidney disease. Maternal age> 40 years in their last child , time of lactation per pregnancy and cumulative time of lactation. Age of the first pregnancy and age of menopause onset.
Self questionnaire diagnostic toolDiagnostic test
Self questionnaire of physical characteristics
Physical ExaminationOther
Physical Examination made by a dermatologist
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients diagnosed with dermatoporosis. A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed. Receives: Other: Questionnaire about associated factors; Diagnostic Test: Self questionnaire diagnostic tool; Other: Physical Examination | |
| Control | Patients not diagnosed with dermatoporosis. A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed. Receives: Other: Questionnaire about associated factors; Diagnostic Test: Self questionnaire diagnostic tool; Other: Physical Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors associated with Dermatoporosis
Presence of factors related to age, sex, personal history of diseases, chronic oral treatments, gyneco-obstetrics background, chronic photoexposure
Measured: At time of enrollment
Diagnostic by self assesment tool
Diagnostic of dermatoporosis made by self assesment tool
Measured: At time of enrollment
Physical examination
Presence of pseudoscars (stellate scars) in the physical examination
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Aug 2018
- Primary completion30 Nov 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Senile PurpuraStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
- Investigators
- Juan Pablo Castanedo-Cazares, PhD, Principal investigator, Universidad Autonoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037604
- Sponsor's protocol ID
- FactorsDermatoporosis
- Acronym
- FAWD
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Database of 315 patients diagnosed and not diagnosed with dermatoporosis will be shared for 3 years. It includes associated factors, physical examination and results of self assesment tool.
Publications
Kaya G, Kaya A, Sorg O, Saurat JH. Dermatoporosis: a further step to recognition. J Eur Acad Dermatol Venereol. 2018 Feb;32(2):189-191. doi: 10.1111/jdv.14777. No abstract available.
PubMed 29465833Han A, Chien AL, Kang S. Photoaging. Dermatol Clin. 2014 Jul;32(3):291-9, vii. doi: 10.1016/j.det.2014.03.015.
PubMed 24891052Kaya 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 17911985Kluger 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 30198583Vanzi V, Toma E. Recognising and managing age-related dermatoporosis and skin tears. Nurs Older People. 2018 Mar 23;30(3):26-31. doi: 10.7748/nop.2018.e1022.
PubMed 29569862Kattoor AJ, Pothineni NVK, Palagiri D, Mehta JL. Oxidative Stress in Atherosclerosis. Curr Atheroscler Rep. 2017 Sep 18;19(11):42. doi: 10.1007/s11883-017-0678-6.
PubMed 28921056Rapa SF, Di Iorio BR, Campiglia P, Heidland A, Marzocco S. Inflammation and Oxidative Stress in Chronic Kidney Disease-Potential Therapeutic Role of Minerals, Vitamins and Plant-Derived Metabolites. Int J Mol Sci. 2019 Dec 30;21(1):263. doi: 10.3390/ijms21010263.
PubMed 31906008Gilchrest BA, Blog FB, Szabo G. Effects of aging and chronic sun exposure on melanocytes in human skin. J Invest Dermatol. 1979 Aug;73(2):141-3. doi: 10.1111/1523-1747.ep12581580.
PubMed 88488Dekel N, Gnainsky Y, Granot I, Mor G. Inflammation and implantation. Am J Reprod Immunol. 2010 Jan;63(1):17-21. doi: 10.1111/j.1600-0897.2009.00792.x.
PubMed 20059465Mor G. Inflammation and pregnancy: the role of toll-like receptors in trophoblast-immune interaction. Ann N Y Acad Sci. 2008 Apr;1127:121-8. doi: 10.1196/annals.1434.006.
PubMed 18443339Michaud M, Balardy L, Moulis G, Gaudin C, Peyrot C, Vellas B, Cesari M, Nourhashemi F. Proinflammatory cytokines, aging, and age-related diseases. J Am Med Dir Assoc. 2013 Dec;14(12):877-82. doi: 10.1016/j.jamda.2013.05.009. Epub 2013 Jun 20.
PubMed 23792036Straub RH, Schradin C. Chronic inflammatory systemic diseases: An evolutionary trade-off between acutely beneficial but chronically harmful programs. Evol Med Public Health. 2016 Jan 27;2016(1):37-51. doi: 10.1093/emph/eow001.
PubMed 26817483Ayala A, Munoz MF, Arguelles S. Lipid peroxidation: production, metabolism, and signaling mechanisms of malondialdehyde and 4-hydroxy-2-nonenal. Oxid Med Cell Longev. 2014;2014:360438. doi: 10.1155/2014/360438. Epub 2014 May 8.
PubMed 24999379Birben E, Sahiner UM, Sackesen C, Erzurum S, Kalayci O. Oxidative stress and antioxidant defense. World Allergy Organ J. 2012 Jan;5(1):9-19. doi: 10.1097/WOX.0b013e3182439613. Epub 2012 Jan 13.
PubMed 23268465Epel ES, Lithgow GJ. Stress biology and aging mechanisms: toward understanding the deep connection between adaptation to stress and longevity. J Gerontol A Biol Sci Med Sci. 2014 Jun;69 Suppl 1(Suppl 1):S10-6. doi: 10.1093/gerona/glu055.
PubMed 24833580
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Dermatoporosis
- ClinicalTrials.gov ID
- NCT05037604
- Acronym / sponsor ID
- FAWD / FactorsDermatoporosis
- Conditions
- Senile Purpura
- Keywords
- dermatoporosis, senile, purpura
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 8 Sep 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.
Dermatoporosis is a chronic syndrome of skin insufficiency or fragility. It is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. Dermatoporosis prevalence is 37% in ≥65 years.
The objective was to determine factors associated with this diagnosis in >60 years old patients of the outpatient clinic in the Hospital Central "Dr. Ignacio Morones Prieto " San Luis Potosí, México.
An observational, cross-sectional, descriptive, and analytical study was performed. Patients >60 years old were selected. A clinical history, clinical examination, and application of a validated diagnostic self-questionnaire were performed.
Detailed description
Dermatoporosis is a chronic syndrome of skin insufficiency or fragility. It is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. Dermatoporosis prevalence is 37% in ≥65 years.The objective was to determine factors associated with this diagnosis in >60 years old patients of the outpatient clinic in the Hospital Central "Dr. Ignacio Morones Prieto " San Luis Potosí, México.
An observational, cross-sectional, descriptive and analytical study was performed. Through consecutive non-probabilistic sampling, patients > 60 years old were selected, who underwent a clinical history, clinical examination, and the application of a validated diagnostic self-questionnaire. To determine the association of the factors, a multivariate logistic regression analysis, it will be used the PRIMERv6 software with the PERMANOVA package. A p <0.05 was considered significant. The normality of the distribution of the continuous variables was evaluated with the Shapiro Wilk test. The Student's t test was performed on variables that met the homogeneity of variance requirements. In the variables that did not meet this criterion, a non-parametric analysis was performed with the Mann U Whitney test. For the analysis of categorical variables, Fisher's exact test or chi-square test was used. Continuous variables were reported by mean (median) [Q1, Q3] (min - max) and by standard deviations as their distribution corresponds. Nominal categorical variables were expressed as frequencies
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Questionnaire about associated factors, Diagnostic Test: Self questionnaire diagnostic tool, Other: Physical ExaminationPatients diagnosed with dermatoporosis. A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed. |
| Control | – | Other: Questionnaire about associated factors, Diagnostic Test: Self questionnaire diagnostic tool, Other: Physical ExaminationPatients not diagnosed with dermatoporosis. A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 60 years of age who attended the outpatient clinic of the Hospital Central "Dr. Ignacio Morones Prieto "
Key inclusion criteria (1 listed)
- Patients over 60 years
Key exclusion criteria (3 listed)
- Patients in whom physical examination cannot be performed due to the use of orthopedic devices such as splints, bandages, etc.
- Patients with whom interviewer-patient verbal communication is difficult due to some hearing or neurological deficit.
- Patients with neurological, psychiatric disorders who are unable to provide reliable information. (disorganized, incoherent speech, cognitive deficit)
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 |
|---|---|---|
| Questionnaire about associated factorsQuestionnaire about age, prolonged sun exposure, intake of anticoagulants / antiplatelets, intake of oral steroids, chronic kidney disease. Maternal age> 40 years in their last child , time of lactation per pregnancy and cumulative time of lactation. Age of the first pregnancy and age of menopause onset. | Other | Cases, Control |
| Self questionnaire diagnostic toolSelf questionnaire of physical characteristics | Diagnostic test | Cases, Control |
| Physical ExaminationPhysical Examination made by a dermatologist | Other | Cases, Control |
Primary outcome
Factors associated with Dermatoporosis
Time frame: At time of enrollment
Presence of factors related to age, sex, personal history of diseases, chronic oral treatments, gyneco-obstetrics background, chronic photoexposure
Diagnostic by self assesment tool
Time frame: At time of enrollment
Diagnostic of dermatoporosis made by self assesment tool
Physical examination
Time frame: At time of enrollment
Presence of pseudoscars (stellate scars) in the physical examination
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 8 Sep 2021.
- Results publication: PubMed 29465833Kaya G, Kaya A, Sorg O, Saurat JH. Dermatoporosis: a further step to recognition. J Eur Acad Dermatol Venereol. 2018 Feb;32(2):189-191. doi: 10.1111/jdv.14777. No abstract available.
- Results publication: PubMed 24891052Han A, Chien AL, Kang S. Photoaging. Dermatol Clin. 2014 Jul;32(3):291-9, vii. doi: 10.1016/j.det.2014.03.015.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 29569862Vanzi V, Toma E. Recognising and managing age-related dermatoporosis and skin tears. Nurs Older People. 2018 Mar 23;30(3):26-31. doi: 10.7748/nop.2018.e1022.
- Results publication: PubMed 28921056Kattoor AJ, Pothineni NVK, Palagiri D, Mehta JL. Oxidative Stress in Atherosclerosis. Curr Atheroscler Rep. 2017 Sep 18;19(11):42. doi: 10.1007/s11883-017-0678-6.
- Results publication: PubMed 31906008Rapa SF, Di Iorio BR, Campiglia P, Heidland A, Marzocco S. Inflammation and Oxidative Stress in Chronic Kidney Disease-Potential Therapeutic Role of Minerals, Vitamins and Plant-Derived Metabolites. Int J Mol Sci. 2019 Dec 30;21(1):263. doi: 10.3390/ijms21010263.
- Results publication: PubMed 88488Gilchrest BA, Blog FB, Szabo G. Effects of aging and chronic sun exposure on melanocytes in human skin. J Invest Dermatol. 1979 Aug;73(2):141-3. doi: 10.1111/1523-1747.ep12581580.
- Results publication: PubMed 20059465Dekel N, Gnainsky Y, Granot I, Mor G. Inflammation and implantation. Am J Reprod Immunol. 2010 Jan;63(1):17-21. doi: 10.1111/j.1600-0897.2009.00792.x.
- Results publication: PubMed 18443339Mor G. Inflammation and pregnancy: the role of toll-like receptors in trophoblast-immune interaction. Ann N Y Acad Sci. 2008 Apr;1127:121-8. doi: 10.1196/annals.1434.006.
- Results publication: PubMed 23792036Michaud M, Balardy L, Moulis G, Gaudin C, Peyrot C, Vellas B, Cesari M, Nourhashemi F. Proinflammatory cytokines, aging, and age-related diseases. J Am Med Dir Assoc. 2013 Dec;14(12):877-82. doi: 10.1016/j.jamda.2013.05.009. Epub 2013 Jun 20.
- Results publication: PubMed 26817483Straub RH, Schradin C. Chronic inflammatory systemic diseases: An evolutionary trade-off between acutely beneficial but chronically harmful programs. Evol Med Public Health. 2016 Jan 27;2016(1):37-51. doi: 10.1093/emph/eow001.
- INEGI. Población. Censos y conteos Población y ViviendaLink provided by the sponsor.
- ADULTOS MAYORES Análisis Integral de su Situación Jurídica en MéxicoLink provided by the sponsor.
- Estimación del tiempo de exposición solar para quemadura en población mexicana.Link provided by the sponsor.
- INEGI. Encuesta Intercensal 2015Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Database of 315 patients diagnosed and not diagnosed with dermatoporosis will be shared for 3 years. It includes associated factors, physical examination and results of self assesment tool.
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.
Juan Pablo Castanedo-Cazares, PhD principal investigator
Universidad Autonoma de San Luis Potosí
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 Senile Purpura, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 1 inclusion and 3 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 8 Sep 2021. 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 Mexico. 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?
Factors associated with Dermatoporosis (time frame: At time of enrollment). The study lists 3 primary outcomes in all. 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 NCT05037604, which also lists 17 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 8 Sep 2021.