Clinical trial NCT02823067: Pruritus and Pemphigoid in Nursing Home Patients
Official title: Pruritus and Pemphigoid in Nursing Home Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pemphigoid
Pruritus
Keywords: Pemphigoid
Bullous pemphigoid
Pruritus
Senile pruritus
Neuropsychiatric symptoms
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 125
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 126 nursing home patients aged 65 years or above, living in a nursing home of the University Network Care of the Elderly - UMCG.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of pruritus
timeFrame: Day 1
measure: Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence on 1M salt-split human skin substrate
timeFrame: Day 1
measure: Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrate
timeFrame: Day 1
measure: Concentration of anti-BP180 NC16A IgG autoantibodies by ELISA
timeFrame: Day 1
measure: Concentration of anti-BP230 IgG autoantibodies by ELISA
timeFrame: Day 1
measure: Detection of circulating pemphigoid specific IgG autoantibodies by immunoblot of keratinocyte extract
timeFrame: Day 1
Secondary outcomes:
measure: Age
timeFrame: Day 1
measure: Sex
timeFrame: Day 1
measure: Comorbidities
timeFrame: Day 1
measure: Karnofsky Performance Scale
timeFrame: Day 1
measure: Medication
timeFrame: Day 1
measure: Neuropsychiatric symptoms
timeFrame: Day 1
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Marcel Jonkman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: