Pruritus and Pemphigoid in Nursing Home Patients

Pruritus Clinical Trial

— SSENIOR  

Official title:

Pruritus and Pemphigoid in Nursing Home Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823067
• Other study ID #: NL56232.042.15
• Secondary ID: METc 2015/605NTR
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: January 1, 2018

Study information

• Verified date: October 2018
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pemphigoid
• Pemphigoid, Bullous
• Pruritus

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
M.F. Jonkman

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of pruritus	Presence 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.	Day 1
Primary	Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence on 1M salt-split human skin substrate	IgG autoantibodies with epidermal side staining of artificial split; positive/negative, staining intensity IgG 1+,2+,3+	Day 1
Primary	Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrate	Anti-basement membrane zone IgG autoantibodies; positive/negative, staining intensity IgG 1+,2+,3+	Day 1
Primary	Concentration of anti-BP180 NC16A IgG autoantibodies by ELISA	Anti-BP180 NC16A IgG index; U/mL, cut-off value 9 U/mL	Day 1
Primary	Concentration of anti-BP230 IgG autoantibodies by ELISA	Anti-BP230 IgG index; U/mL, cut-off value 9 U/mL	Day 1
Primary	Detection of circulating pemphigoid specific IgG autoantibodies by immunoblot of keratinocyte extract	Presence/absence of circulating IgG autoantibodies against BP180 (180kDa) or BP230 (230kDa)	Day 1
Secondary	Age	For all subjects	Day 1
Secondary	Sex	For all subjects	Day 1
Secondary	Comorbidities	Presence/absence of comorbidities dementia, cerebrovascular accident, Parkinson's disease, other neurological disease or other diseases	Day 1
Secondary	Karnofsky Performance Scale	0% - 100%	Day 1
Secondary	Medication	Registration of medication use for all subjects	Day 1
Secondary	Neuropsychiatric symptoms	Neuropsychiatric Inventory - Nursing Home version in Dutch	Day 1