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
Qualifiers
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
Treatments tested in this trial
- Skin sampling
Treatment groups
144 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov