Self-collection of skin samples for diagnosing scabies
Sensitivity of Self-collected Skin Sampling for Scabies: a Pilot Study
EARLY_PHASE1 · Radboud University Medical Center · NCT06546579
This study is testing whether people can accurately collect their own skin samples to help diagnose scabies, compared to samples taken by professionals.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center (other) |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT06546579 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of self-collected skin samples in diagnosing scabies compared to professional sampling methods. Healthy adults aged 18 and older with suspected or confirmed scabies will participate, providing skin samples during a standard care visit. The study will assess the sensitivity of these self-collected samples and compare the results of polymerase chain reaction (PCR) testing against traditional microscopy. The goal is to improve diagnostic accuracy while addressing issues of autonomy and privacy for patients.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older with suspected, clinical, or confirmed scabies.
Not a fit: Patients who have been treated for scabies in the last six weeks or have immunosuppressive conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy and accessibility of scabies diagnosis for patients.
How similar studies have performed: While the approach of self-collection is innovative, similar studies exploring PCR for scabies diagnosis have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Have either suspected scabies, clinical scabies or confirmed scabies (see table 1) * Providing informed consent (IC) Exclusion Criteria: * 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. * Individuals with immunosuppressive conditions (see appendix A). * Any other condition, finding or situation which, in the opinion of the investigator, may significantly increase the risk to the individual because of participation in the study, affect the ability of the individual to participate in the study or impair interpretation of the study data.
Where this trial is running
Nijmegen, Gelderland
- Radboudumc — Nijmegen, Gelderland, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Matthew MC McCall, PhD
- Email: matthew.mccall@radboudumc.nl
- Phone: 024 361 1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Scabies