NCT06546579

Sensitivity of Self-collected Skin Sampling for Scabies: a Pilot Study

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Scabies

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Skin sampling	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.

Timeline

• Start date: 2024-08-21
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: Netherlands