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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2025-06-30

Brief Summary

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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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Skin Infections

UNKNOWN

Detailed Description

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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

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Scabies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study design is cross-sectional in terms of the diagnostic process, which aims to determine the presence of scabies in an individual at a specific point in time. All participants will undergo the same diagnostic procedures.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Skin sampling

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes