Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-31 @ 12:07 PM
Study NCT ID:
NCT05037604
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2021-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Dermatoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011693', 'term': 'Purpura'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2021-08-23', 'studyFirstSubmitQcDate': '2021-08-30', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Factors associated with Dermatoporosis', 'timeFrame': 'At time of enrollment', 'description': 'Presence of factors related to age, sex, personal history of diseases, chronic oral treatments, gyneco-obstetrics background, chronic photoexposure'}, {'measure': 'Diagnostic by self assesment tool', 'timeFrame': 'At time of enrollment', 'description': 'Diagnostic of dermatoporosis made by self assesment tool'}, {'measure': 'Physical examination', 'timeFrame': 'At time of enrollment', 'description': 'Presence of pseudoscars (stellate scars) in the physical examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dermatoporosis', 'senile', 'purpura'], 'conditions': ['Senile Purpura']}, 'referencesModule': {'references': [{'pmid': '29465833', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24891052', 'type': 'RESULT', 'citation': 'Han A, Chien AL, Kang S. Photoaging. Dermatol Clin. 2014 Jul;32(3):291-9, vii. doi: 10.1016/j.det.2014.03.015.'}, {'pmid': '17911985', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '30198583', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '29569862', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '28921056', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '31906008', 'type': 'RESULT', 'citation': '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):263. doi: 10.3390/ijms21010263.'}, {'pmid': '88488', 'type': 'RESULT', 'citation': '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. doi: 10.1111/1523-1747.ep12581580.'}, {'pmid': '20059465', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '18443339', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23792036', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26817483', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24999379', 'type': 'RESULT', 'citation': 'Ayala 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.'}, {'pmid': '23268465', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24833580', 'type': 'RESULT', 'citation': '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(Suppl 1):S10-6. doi: 10.1093/gerona/glu055.'}, {'pmid': '9989696', 'type': 'RESULT', 'citation': '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. doi: 10.1093/ajcn/69.2.299.'}, {'pmid': '21787367', 'type': 'RESULT', 'citation': '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. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.inegi.org.mx/contenidos/productos/prod_serv/contenidos/espanol/bvinegi/productos/nueva_estruc/AEGEUM_2018/702825107000.pdf', 'label': 'INEGI. Población. Censos y conteos Población y Vivienda'}, {'url': 'http://www.diputados.gob.mx/sedia/sia/spi/SAPI-ISS-11-17.pdf', 'label': 'ADULTOS MAYORES Análisis Integral de su Situación Jurídica en México'}, {'url': 'https://www.medigraphic.com/cgi-bin/new/resumen.cgi?IDARTICULO=35548', 'label': 'Estimación del tiempo de exposición solar para quemadura en población mexicana.'}, {'url': 'https://www.inegi.org.mx/contenidos/productos/prod_serv/contenidos/espanol/bvinegi/productos/nueva_estruc/AEGEUM_2018/702825107000.pdf', 'label': 'INEGI. Encuesta Intercensal 2015'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nAn 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.', 'detailedDescription': '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.\n\nAn 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 60 years of age who attended the outpatient clinic of the Hospital Central "Dr. Ignacio Morones Prieto "', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 60 years\n\nExclusion Criteria:\n\n* Patients in whom physical examination cannot be performed due to the use of orthopedic devices such as splints, bandages, etc.\n* Patients with whom interviewer-patient verbal communication is difficult due to some hearing or neurological deficit.\n* Patients with neurological, psychiatric disorders who are unable to provide reliable information. (disorganized, incoherent speech, cognitive deficit)'}, 'identificationModule': {'nctId': 'NCT05037604', 'acronym': 'FAWD', 'briefTitle': 'Factors Associated With Dermatoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de San Luis Potosí'}, 'officialTitle': 'Factors Associated With Dermatoporosis', 'orgStudyIdInfo': {'id': 'FactorsDermatoporosis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients diagnosed with dermatoporosis. A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed.', 'interventionNames': ['Other: Questionnaire about associated factors', 'Diagnostic Test: Self questionnaire diagnostic tool', 'Other: Physical Examination']}, {'label': 'Control', 'description': 'Patients not diagnosed with dermatoporosis. A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed.', 'interventionNames': ['Other: Questionnaire about associated factors', 'Diagnostic Test: Self questionnaire diagnostic tool', 'Other: Physical Examination']}], 'interventions': [{'name': 'Questionnaire about associated factors', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Cases', 'Control']}, {'name': 'Self questionnaire diagnostic tool', 'type': 'DIAGNOSTIC_TEST', 'description': 'Self questionnaire of physical characteristics', 'armGroupLabels': ['Cases', 'Control']}, {'name': 'Physical Examination', 'type': 'OTHER', 'description': 'Physical Examination made by a dermatologist', 'armGroupLabels': ['Cases', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78220', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'Hospital Central "Dr. Ignacio Morones Prieto"', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}], 'overallOfficials': [{'name': 'Juan Pablo Castanedo-Cazares, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Autonoma de San Luis Potosí'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '3 years', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'The database will be shared with researchers who require it by means of a letter sent to the principle investigator justifying its use for research and attaching a letter that describes the privacy policy to safeguard the information contained in the database.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de San Luis Potosí', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Juan Pablo Castanedo-Cazares', 'investigatorAffiliation': 'Universidad Autonoma de San Luis Potosí'}}}}