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NCT Number: NCT06546579

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

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.

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Key information

Conditions

Scabies Ectoparasitic Infestations Infections Mite Infestations Parasitic Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skin sampling

Diagnostic Test

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.

Primary outcomes

  1. The sensitivity of self-collected skin samples for diagnosing scabies

    Time frame: through study completion, an average of one year

    The proportion of self-collected samples collected at the enrolment visit that are tested positive, divided by the total number of participants adjudged retrospectively to have had scabies at their enrolment visit, based on a composite clinical diagnosis.

  2. The sensitivity of professionally-collected skin samples for diagnosing scabies

    Time frame: through study completion, an average of one year

    The proportion of professionally-collected samples collected at the enrolment visit that are tested positive, divided by the total number of participants adjudged retrospectively to have had scabies at their enrolment visit, based on a composite clinical diagnosis.

Secondary outcomes

  1. The sensitivity of skin scrapings for diagnosing scabies

    Time frame: through study completion, an average of one year

    The proportion of skin scrapings at their enrolment visit (whether professionally or self-collected) that are tested positive by PCR, divided by the total number of participants adjudged retrospectively to have had scabies at baseline, based on a composite clinical diagnosis.

  2. The sensitivity of skin swabs for diagnosing scabies

    Time frame: through study completion, an average of one year

    The proportion of skin swabs at their enrolment visit (whether professionally or self-collected) that are tested positive by PCR, divided by the total number of participants adjudged retrospectively to have had scabies at baseline, based on a composite clinical diagnosis.

  3. The sensitivity and specificity of PCR on skin scraping for diagnosing active scabies infection

    Time frame: through study completion

    The proportion of participants adjudged to have had scabies at their enrolment visit (based on a retrospective composite clinical diagnosis), whose skin scraping at their enrolment visit (whether professionally or self-collected) are tested positive for scabies by PCR, and the proportion of participants adjudged retrospectively to have not had scabies at their enrolment visit whose skin scrapings are tested negative for scabies by PCR.

  4. The sensitivity and specificity of microscopy on skin scraping for diagnosing active scabies infection

    Time frame: through study completion, an average of one year

    The proportion of participants adjudged to have had scabies at their enrolment visit (based on a retrospective composite clinical diagnosis), whose skin scraping at their enrolment visit (whether professionally or self-collected) are tested positive for scabies by microscopy, and the proportion of participants adjudged retrospectively to have not had scabies at their enrolment visit whose skin scrapings are tested negative* for scabies by microscopy.

Other outcomes

  1. Proportion of participants whose self-sampling location is judged appropriate

    Time frame: through study completion, an average of one year

    Assessed by a professional at T=0 [adequate/non-adequate]

  2. Motivation for self-collection of skin samples for scabies diagnostics

    Time frame: through study completion, an average of one year

    Motivation is assessed by items on the questionnaire related to the motivation for self-collection of skin samples for scabies diagnostics, along with the associated facilitators and barriers.

  3. Demographic, clinical and epidemiological factors which influence the sensitivity of self-collected skin samples for scabies diagnosis.

    Time frame: through study completion, an average of one year

    Age, gender, highest level of education, signs/symptoms, living situation, skin color. source of transmission and transmission mode.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: SCRAPE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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