Clinical trial NCT06546579: Sensitivity of Self-collected Skin Sampling for Scabies: a Pilot Study
Official title: Sensitivity of Self-collected Skin Sampling for Scabies: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Scabies
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is cross-sectional in terms of the diagnostic process, which aims to determine the presence of scabies in an individual at a specific point in time. All participants will undergo the same diagnostic procedures.
Primary purpose: DIAGNOSTIC

Brief summary: In this cross-sectional diagnostic study, healthy adults aged 18 and older with suspected, clinical, or confirmed scabies will be recruited. The objective is to determine if the sensitivity of self-collected skin samples for scabies diagnosis is non-inferior to professional sampling, and compare the sensitivity and specificity of the polymerase chain reaction assay (PCR) versus microscopy.

Detailed description: Scabies infestations have significantly increased globally in the last 10-20 years, including a threefold rise in the Netherlands over the past decade. Diagnosing scabies is challenging due to varied symptoms and low sensitivity of current microscopic methods. New diagnostic techniques like PCR, which offer higher sensitivity, are being investigated. The feasibility of self-collected skin samples is being explored to reduce the burden on healthcare services and address issues like autonomy, stigma, and privacy.

In this cross-sectional diagnostic study, healthy adults aged 18 and older with suspected, clinical, or confirmed scabies will be included. Primary endpoint is the sensitivity of self-collected versus professional skin samples for diagnosing scabies. Secondary endpoints include sensitivity of skin scrapings and swabs, and the sensitivity and specificity of PCR versus microscopy.

Participants will self-collect skin samples during a standard care visit. The process may be slightly sensitive but not painful. There are no direct benefits beyond standard care.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Have either suspected scabies, clinical scabies or confirmed scabies (see table 1)
* Providing informed consent (IC)

Exclusion Criteria:

* Individuals not speaking or understanding the Dutch or English language.
* Individuals who have been diagnosed with scabies in the last six weeks and had started treatment.
* Individuals who have used ivermectin for other diagnoses than scabies in the last six weeks.
* Individuals younger than 18 years.
* Individuals with immunosuppressive conditions (see appendix A).
* Any other condition, finding or situation which, in the opinion of the investigator, may significantly increase the risk to the individual because of participation in the study, affect the ability of the individual to participate in the study or impair interpretation of the study data.

Primary outcomes:
measure: The sensitivity of self-collected skin samples for diagnosing scabies
timeFrame: through study completion, an average of one year
measure: The sensitivity of professionally-collected skin samples for diagnosing scabies
timeFrame: through study completion, an average of one year
Secondary outcomes:
measure: The sensitivity of skin scrapings for diagnosing scabies
timeFrame: through study completion, an average of one year
measure: The sensitivity of skin swabs for diagnosing scabies
timeFrame: through study completion, an average of one year
measure: The sensitivity and specificity of PCR on skin scraping for diagnosing active scabies infection
timeFrame: through study completion
measure: The sensitivity and specificity of microscopy on skin scraping for diagnosing active scabies infection
timeFrame: through study completion, an average of one year
Other outcomes:
measure: Proportion of participants whose self-sampling location is judged appropriate
timeFrame: through study completion, an average of one year
measure: Motivation for self-collection of skin samples for scabies diagnostics
timeFrame: through study completion, an average of one year
measure: Demographic, clinical and epidemiological factors which influence the sensitivity of self-collected skin samples for scabies diagnosis.
timeFrame: through study completion, an average of one year
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: