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Self-collection of skin samples to diagnose scabies

Sensitivity of self-Collected skin sAmPling for scabiEs: a pilot study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN42981348
Enrollment
144
Registered
2025-08-20
Start date
2024-07-24
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scabies Infections and Infestations

Interventions

Adults presenting to routine (public) health facilities with suspicion of scabies first perform self-sampling consisting of skin scrapings and a subsequent skin swab. Sampling (skin scrapings and subs

Sponsors

Radboud University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years or older 2. Attending a participating scabies outpatient clinic or dermatology outpatient clinic with suspicion of scabies 3. Providing written informed consent

Exclusion criteria

Exclusion criteria: 1. Individuals not speaking or understanding the Dutch or English language 2. Individuals who have been diagnosed with scabies in the last four weeks and have started treatment 3. Individuals who have used ivermectin for other diagnoses than scabies in the last 6 weeks 4. Individuals younger than 18 years 5. Individuals with immunosuppressive conditions 6. 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

Design outcomes

Primary

MeasureTime frame
Positivity of self-collected samples (defined as qPCR- and/or microscopy-positive on self-collected skin scrapings and/or self-collected skin swab) compared with positivity of professionally collected samples (defined as qPCR- and/or microscopy-positive on professionally collected skin scrapings and/or professionally collected skin swab); all samples are collected at baseline

Secondary

MeasureTime frame
1. Positivity of skin scrapings (defined as qPCR- and/or microscopy-positive on self-collected and/or professionally collected skin scrapings) compared with positivity of skin swabs (defined as qPCR-positive on self-collected and/or professionally collected skin swabs) ; all samples are collected at baseline 2. Positivity by qPCR (defined as qPCR-positive on self-collected and/or professionally collected skin scrapings) compared with positivity by microscopy (defined as microscopy-positive on self-collected and/or professionally collected skin scrapings); all samples are collected at baseline

Countries

Netherlands

Contacts

Public ContactMatthew McCall
matthew.mccall@radboudumc.nl+31 (0)243614356

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026