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Completed

NCT Number: NCT02823067

Pruritus and Pemphigoid in Nursing Home Patients

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.

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Key information

Conditions

Pemphigoid Autoimmune Diseases Immune System Diseases Pathological Conditions, Signs and Symptoms Pemphigoid, Bullous Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Vesiculobullous Skin Manifestations Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

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

Primary outcomes

  1. Presence of pruritus

    Time frame: Day 1

    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.

  2. Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence on 1M salt-split human skin substrate

    Time frame: Day 1

    IgG autoantibodies with epidermal side staining of artificial split; positive/negative, staining intensity IgG 1+,2+,3+

  3. Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrate

    Time frame: Day 1

    Anti-basement membrane zone IgG autoantibodies; positive/negative, staining intensity IgG 1+,2+,3+

  4. Concentration of anti-BP180 NC16A IgG autoantibodies by ELISA

    Time frame: Day 1

    Anti-BP180 NC16A IgG index; U/mL, cut-off value 9 U/mL

  5. Concentration of anti-BP230 IgG autoantibodies by ELISA

    Time frame: Day 1

    Anti-BP230 IgG index; U/mL, cut-off value 9 U/mL

  6. Detection of circulating pemphigoid specific IgG autoantibodies by immunoblot of keratinocyte extract

    Time frame: Day 1

    Presence/absence of circulating IgG autoantibodies against BP180 (180kDa) or BP230 (230kDa)

Secondary outcomes

  1. Age

    Time frame: Day 1

    For all subjects

  2. Sex

    Time frame: Day 1

    For all subjects

  3. Comorbidities

    Time frame: Day 1

    Presence/absence of comorbidities dementia, cerebrovascular accident, Parkinson's disease, other neurological disease or other diseases

  4. Karnofsky Performance Scale

    Time frame: Day 1

    0% - 100%

  5. Medication

    Time frame: Day 1

    Registration of medication use for all subjects

  6. Neuropsychiatric symptoms

    Time frame: Day 1

    Neuropsychiatric Inventory - Nursing Home version in Dutch

Sponsors and collaborators

Lead sponsor

M.F. Jonkman

Other

Registry information

Acronym: SSENIOR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2016
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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