Sensitivity of Self-collected Skin Sampling for Scabies: a Pilot Study
ConditionScabies
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years or older
Have either suspected scabies, clinical scabies or confirmed scabies (see table 1)
Providing informed consent (IC)
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Skin sampling
Diagnostic testAll 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.
Treatment groups
144 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The sensitivity of self-collected skin samples for diagnosing scabies
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 year2
The sensitivity of professionally-collected skin samples for diagnosing scabies
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 yearSecondary outcomes
1
The sensitivity of skin scrapings for diagnosing scabies
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 year2
The sensitivity of skin swabs for diagnosing scabies
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, an average of one year3
The sensitivity and specificity of PCR on skin scraping for diagnosing active scabies infection
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 completion4
The sensitivity and specificity of microscopy on skin scraping for diagnosing active scabies infection
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 yearOther outcomes
1
Proportion of participants whose self-sampling location is judged appropriate
Assessed by a professional at T=0 \[adequate/non-adequate\]
Time frame
through study completion, an average of one year2
Motivation for self-collection of skin samples for scabies diagnostics
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 year3
Demographic, clinical and epidemiological factors which influence the sensitivity of self-collected skin samples for scabies diagnosis.
Age, gender, highest level of education, signs/symptoms, living situation, skin color. source of transmission and transmission mode.
Time frame
through study completion, an average of one yearSponsors and contacts
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Source ClinicalTrials.gov