- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05037604
Factors Associated With Dermatoporosis (FAWD)
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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San Luis Potosi, Meksyk, 78220
- Hospital Central "Dr. Ignacio Morones Prieto"
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Patients over 60 years
Exclusion Criteria:
- 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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kontrola przypadków
- Perspektywy czasowe: Przekrojowe
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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Cases
Patients diagnosed with dermatoporosis.
A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed.
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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 of physical characteristics
Physical Examination made by a dermatologist
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Control
Patients not diagnosed with dermatoporosis.
A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed.
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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 of physical characteristics
Physical Examination made by a dermatologist
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Factors associated with Dermatoporosis
Ramy czasowe: At time of enrollment
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Presence of factors related to age, sex, personal history of diseases, chronic oral treatments, gyneco-obstetrics background, chronic photoexposure
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At time of enrollment
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Diagnostic by self assesment tool
Ramy czasowe: At time of enrollment
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Diagnostic of dermatoporosis made by self assesment tool
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At time of enrollment
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Physical examination
Ramy czasowe: At time of enrollment
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Presence of pseudoscars (stellate scars) in the physical examination
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At time of enrollment
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Juan Pablo Castanedo-Cazares, PhD, Universidad Autonoma de San Luis Potosí
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- Han A, Chien AL, Kang S. Photoaging. Dermatol Clin. 2014 Jul;32(3):291-9, vii. doi: 10.1016/j.det.2014.03.015. Review.
- Kaya G, Saurat JH. Dermatoporosis: a chronic cutaneous insufficiency/fragility syndrome. Clinicopathological features, mechanisms, prevention and potential treatments. Dermatology. 2007;215(4):284-94. Review.
- Kluger 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.
- Vanzi 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.
- Kattoor 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. Review.
- Rapa 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). pii: E263. doi: 10.3390/ijms21010263. Review.
- Gilchrest 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.
- Dekel 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. Review.
- Mor 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. Review.
- Michaud 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. Review.
- Straub 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. Review.
- Ayala A, Muñoz MF, Argüelles 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. Review.
- Birben 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.
- Epel 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:S10-6. doi: 10.1093/gerona/glu055. Review.
- Butte NF, Hopkinson JM, Mehta N, Moon JK, Smith EO. Adjustments in energy expenditure and substrate utilization during late pregnancy and lactation. Am J Clin Nutr. 1999 Feb;69(2):299-307.
- Mengeaud 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.
Przydatne linki
- INEGI. Población. Censos y conteos Población y Vivienda
- ADULTOS MAYORES Análisis Integral de su Situación Jurídica en México
- The metabolic syndrome: linking oxidative stress and inflammation to obesity, type 2 diabetes, and the syndrome
- Estimación del tiempo de exposición solar para quemadura en población mexicana.
- INEGI. Encuesta Intercensal 2015
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FactorsDermatoporosis
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- Protokół badania
- Plan analizy statystycznej (SAP)
- Formularz świadomej zgody (ICF)
- Raport z badania klinicznego (CSR)
- Kod analityczny
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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