NCT Number: NCT06546579
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Nijmegen, Gelderland, 6525GA, Netherlands
Location status: Recruiting
Jeannine Hautvast, PhD
PRINCIPAL_INVESTIGATOR
Matthew MC McCall, PhD
CONTACT
024 361 1111 ext. +31
Saskia C van der Boor, PhD
CONTACT
024 361 1111 ext. +31
Stijn Raven, PhD
PRINCIPAL_INVESTIGATOR
Suzanne Roos-Soethoudt, MSc
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All individuals will self-collect skin samples and swabs and fill in a questionnaire. Subsequently, all individuals will see a professional. The professional will collect skin samples and swabs as well.
Time frame: through study completion, an average of one year
The proportion of self-collected samples collected at the enrolment visit that are tested positive, divided by the total number of participants adjudged retrospectively to have had scabies at their enrolment visit, based on a composite clinical diagnosis.
Time frame: through study completion, an average of one year
The proportion of professionally-collected samples collected at the enrolment visit that are tested positive, divided by the total number of participants adjudged retrospectively to have had scabies at their enrolment visit, based on a composite clinical diagnosis.
Time frame: through study completion, an average of one year
The proportion of skin scrapings at their enrolment visit (whether professionally or self-collected) that are tested positive by PCR, divided by the total number of participants adjudged retrospectively to have had scabies at baseline, based on a composite clinical diagnosis.
Time frame: through study completion, an average of one year
The proportion of skin swabs at their enrolment visit (whether professionally or self-collected) that are tested positive by PCR, divided by the total number of participants adjudged retrospectively to have had scabies at baseline, based on a composite clinical diagnosis.
Time frame: through study completion
The proportion of participants adjudged to have had scabies at their enrolment visit (based on a retrospective composite clinical diagnosis), whose skin scraping at their enrolment visit (whether professionally or self-collected) are tested positive for scabies by PCR, and the proportion of participants adjudged retrospectively to have not had scabies at their enrolment visit whose skin scrapings are tested negative for scabies by PCR.
Time frame: through study completion, an average of one year
The proportion of participants adjudged to have had scabies at their enrolment visit (based on a retrospective composite clinical diagnosis), whose skin scraping at their enrolment visit (whether professionally or self-collected) are tested positive for scabies by microscopy, and the proportion of participants adjudged retrospectively to have not had scabies at their enrolment visit whose skin scrapings are tested negative* for scabies by microscopy.
Time frame: through study completion, an average of one year
Assessed by a professional at T=0 [adequate/non-adequate]
Time frame: through study completion, an average of one year
Motivation is assessed by items on the questionnaire related to the motivation for self-collection of skin samples for scabies diagnostics, along with the associated facilitators and barriers.
Time frame: through study completion, an average of one year
Age, gender, highest level of education, signs/symptoms, living situation, skin color. source of transmission and transmission mode.
Contact information is provided by the study sponsor or research team.
Matthew MC McCall, PhD
CONTACT
024 361 1111 ext. +31
Saskia C van der Boor, PhD
CONTACT
024 361 1111 ext. +31
Radboud University Medical Center
Other
Acronym: SCRAPE
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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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