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

NCT06546579 | Recruiting Early Phase 1

• 1 other identifier: NL86424.091.24
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scabies

Outcome Measures

Primary Outcomes (2)

• The sensitivity of self-collected skin samples for diagnosing scabies

  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.

  through study completion, an average of one year

• The sensitivity of professionally-collected skin samples for diagnosing scabies

  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.

  through study completion, an average of one year

Secondary Outcomes (4)

• The sensitivity of skin scrapings for diagnosing scabies

  through study completion, an average of one year

• The sensitivity of skin swabs for diagnosing scabies

  through study completion, an average of one year

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

  through study completion

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

  through study completion, an average of one year

Other Outcomes (3)

• Proportion of participants whose self-sampling location is judged appropriate

  through study completion, an average of one year

• Motivation for self-collection of skin samples for scabies diagnostics

  through study completion, an average of one year

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

  through study completion, an average of one year

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Diagnostic Test: Skin sampling

Interventions

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Have either suspected scabies, clinical scabies or confirmed scabies (see table 1)
• Providing informed consent (IC)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Scabies

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Matthew MC McCall, PhD

CONTACT

024 361 1111; matthew.mccall@radboudumc.nl

Saskia C van der Boor, PhD

CONTACT

024 361 1111; saskia.vanderboor@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 9, 2024
• Study Start: August 21, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)