Sensitivity of Self-collected Skin Sampling for Scabies: a Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 18 years or older
• Have either suspected scabies, clinical scabies or confirmed scabies (see table 1)
• Providing informed consent (IC)
Locations
Other Locations
Netherlands
Radboudumc
RECRUITING
Nijmegen
Contact Information
Primary
Matthew MC McCall, PhD
matthew.mccall@radboudumc.nl
024 361 1111
Backup
Saskia C van der Boor, PhD
saskia.vanderboor@radboudumc.nl
024 361 1111
Time Frame
Start Date: 2024-08-21
Estimated Completion Date: 2025-06
Participants
Target number of participants: 144
Treatments
Experimental: Experimental group
All participants will be asked to perform self-sampling and irrespective of the result will receive current standard-of-care from their health care provider for their suspected scabies.
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center