Skip to content

Pruritus and Pemphigoid in Nursing Home Patients

Pruritus and Pemphigoid in Nursing Home Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02823067
Acronym
SSENIOR
Enrollment
125
Registered
2016-07-06
Start date
2016-06-01
Completion date
2018-01-01
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pemphigoid, Pruritus

Keywords

Pemphigoid, Bullous pemphigoid, Pruritus, Senile pruritus, Neuropsychiatric symptoms

Brief summary

The primary objective of this observational study is to describe the prevalence of pruritus and pemphigoid in nursing home patients. Secondary outcomes are the relationships of demographic factors and medical risk factors with pemphigoid, including dementia and neuropsychiatric symptoms, medication use and Karnofsky score.

Detailed description

Pruritus or itch is the most common skin symptom in elderly patients and is estimated to affect more than 30% of nursing home patients. Clinical and experimental evidence suggests pruritus in elderly patients may be linked to pemphigoid. Pemphigoid is the most common autoimmune skin blistering diseases and mainly affects the elderly. It is successfully treatable with systemic therapy. However, pemphigoid is often missed as a cause of pruritus in elderly patients (nonbullous cutaneous pemphigoid). Although nursing home patients and patients with dementia in particular have the highest risk for development of pemphigoid, no study has been performed in this population so far. Including serological screening for pemphigoid in the diagnostic evaluation of chronic pruritus in nursing home patients may lead to the diagnosis of pemphigoid. Furthermore, chronic itch may be an unrecognized cause of neuropsychiatric symptoms in nursing home patients with dementia.

Interventions

OTHERBlood sample

One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing.

Sponsors

M.F. Jonkman
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Inpatient of a nursing home * Age 65 years or above * Subject or their official representatives have signed informed consent

Exclusion criteria

* Age below 65 years * Subjects who do not have signed informed consent * Receiving treatment with any systemic immunosuppressive agents * Terminally ill patients with a life expectancy of less than 4 weeks

Design outcomes

Primary

MeasureTime frameDescription
Detection of circulating pemphigoid specific IgG autoantibodies by immunoblot of keratinocyte extractDay 1Presence/absence of circulating IgG autoantibodies against BP180 (180kDa) or BP230 (230kDa)
Presence of pruritusDay 1Presence and intensity of pruritus will be determined (hetero-)anamnestically with the Bullous Pemphigoid Disease Area Index (BPDAI) VAS score and derivative score for all subjects.
Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence on 1M salt-split human skin substrateDay 1IgG autoantibodies with epidermal side staining of artificial split; positive/negative, staining intensity IgG 1+,2+,3+
Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrateDay 1Anti-basement membrane zone IgG autoantibodies; positive/negative, staining intensity IgG 1+,2+,3+
Concentration of anti-BP180 NC16A IgG autoantibodies by ELISADay 1Anti-BP180 NC16A IgG index; U/mL, cut-off value 9 U/mL
Concentration of anti-BP230 IgG autoantibodies by ELISADay 1Anti-BP230 IgG index; U/mL, cut-off value 9 U/mL

Secondary

MeasureTime frameDescription
AgeDay 1For all subjects
SexDay 1For all subjects
ComorbiditiesDay 1Presence/absence of comorbidities dementia, cerebrovascular accident, Parkinson's disease, other neurological disease or other diseases
Karnofsky Performance ScaleDay 10% - 100%
MedicationDay 1Registration of medication use for all subjects
Neuropsychiatric symptomsDay 1Neuropsychiatric Inventory - Nursing Home version in Dutch

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026