Factors Associated With Dermatoporosis

Senile Purpura Clinical Trial

— FAWD  

Official title:

Factors Associated With Dermatoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037604
• Other study ID #: FactorsDermatoporosis
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: August 2021
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: April 30, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Purpura
• Senile Purpura

Intervention

Other:
• Questionnaire about associated factors
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.

Diagnostic Test:
• Self questionnaire diagnostic tool
Self questionnaire of physical characteristics

Other:
• Physical Examination
Physical Examination made by a dermatologist

Locations

Country	Name	City	State
Mexico	Hospital Central "Dr. Ignacio Morones Prieto"	San Luis Potosi

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

References & Publications (17)

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. — View 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. — View 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. — View 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. Review. — View 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:S10-6. doi: 10.1093/gerona/glu055. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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 — View 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. — View 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. Review. — View 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. Review. — View 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). pii: E263. doi: 10.339 — View 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. Review. — View 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors associated with Dermatoporosis	Presence of factors related to age, sex, personal history of diseases, chronic oral treatments, gyneco-obstetrics background, chronic photoexposure	At time of enrollment
Primary	Diagnostic by self assesment tool	Diagnostic of dermatoporosis made by self assesment tool	At time of enrollment
Primary	Physical examination	Presence of pseudoscars (stellate scars) in the physical examination	At time of enrollment

External Links

•   ADULTOS MAYORES Análisis Integral de su Situación Jurídica en México
•   Estimación del tiempo de exposición solar para quemadura en población mexicana.
•   INEGI. Encuesta Intercensal 2015
•   INEGI. Población. Censos y conteos Población y Vivienda
•   The metabolic syndrome: linking oxidative stress and inflammation to obesity, type 2 diabetes, and the syndrome