NCT05037604

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

August 23, 2021

Last Update Submit

August 30, 2021

Conditions

Senile Purpura

Keywords

dermatoporosissenilepurpura

Outcome Measures

Primary Outcomes (3)

  • 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

  • Diagnostic by self assesment tool

    Diagnostic of dermatoporosis made by self assesment tool

    At time of enrollment

  • Physical examination

    Presence of pseudoscars (stellate scars) in the physical examination

    At time of enrollment

Study Arms (2)

Cases

Patients diagnosed with dermatoporosis. A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed.

Other: Questionnaire about associated factorsDiagnostic Test: Self questionnaire diagnostic toolOther: Physical Examination

Control

Patients not diagnosed with dermatoporosis. A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed.

Other: Questionnaire about associated factorsDiagnostic Test: Self questionnaire diagnostic toolOther: Physical Examination

Interventions

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.

CasesControl
Self questionnaire diagnostic toolDIAGNOSTIC_TEST

Self questionnaire of physical characteristics

CasesControl
Physical ExaminationOTHER

Physical Examination made by a dermatologist

CasesControl

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 60 years of age who attended the outpatient clinic of the Hospital Central "Dr. Ignacio Morones Prieto "

You may qualify if:

  • Patients over 60 years

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, 78220, Mexico

Location

Related Publications (17)

  • 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: 29465833RESULT

  • 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: 24891052RESULT

  • 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: 17911985RESULT

  • 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: 30198583RESULT

  • 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: 29569862RESULT

  • 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: 28921056RESULT

  • 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: 31906008RESULT

  • 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: 88488RESULT

  • 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: 20059465RESULT

  • 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: 18443339RESULT

  • 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: 23792036RESULT

  • 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: 26817483RESULT

  • 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: 24999379RESULT

  • 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: 23268465RESULT

  • 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: 24833580RESULT

  • 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: 9989696RESULT

  • 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.

    PMID: 21787367RESULT

Related Links

MeSH Terms

Conditions

Purpura

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Juan Pablo Castanedo-Cazares, PhD

    Universidad Autonoma de San Luis Potosí

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 23, 2021

First Posted

September 8, 2021

Study Start

August 1, 2018

Primary Completion

November 30, 2018

Study Completion

April 30, 2019

Last Updated

September 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
3 years
Access Criteria
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.

Locations

ME(1)