Actively Recruiting
Sensitivity of Self-collected Skin Sampling for Scabies: a Pilot Study
Led by Radboud University Medical Center · Updated on 2024-08-09
144
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new method for diagnosing scabies, a skin condition caused by mites. This cross-sectional diagnostic study includes healthy adults aged 18 and older who have suspected, clinical, or confirmed scabies. The study aims to compare the sensitivity of self-collected skin samples with those collected by healthcare professionals and to evaluate the effectiveness of a PCR test against traditional microscopy for detecting scabies. Participants will collect their own skin samples and swabs during a regular healthcare visit and complete a questionnaire. Afterwards, a healthcare professional will also collect skin samples and swabs for comparison. All participants will receive the current standard care for their suspected scabies regardless of the test results. Throughout the study, researchers will measure how well self-collected samples detect scabies compared to professional samples, and assess the accuracy of PCR and microscopy tests. The study involves no additional treatments beyond standard care and may include some mild discomfort during sample collection. Participation is expected to last about one year, during which participants' samples and diagnostic results are monitored.
CONDITIONS
Brief Title
Sensitivity of Self-collected Skin Sampling for Scabies: a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Have suspected, clinical, or confirmed scabies
- Provide informed consent
You will not qualify if you...
- Do not speak or understand Dutch or English
- Diagnosed with scabies and started treatment within the last six weeks
- Used ivermectin for conditions other than scabies in the last six weeks
- Younger than 18 years
- Have immunosuppressive conditions
- Any condition or situation that increases risk, affects participation ability, or impairs data interpretation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants self-collect skin samples and swabs during a standard care visit, followed by professional collection of skin samples and swabs to diagnose scabies.
1 visit (in-person)
Duration - Up to 1 year
Participants are observed for up to one year to evaluate the sensitivity and specificity of diagnostic methods for scabies.
No additional visits required
Trial Site Locations
Total: 1 location
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525GA
Actively Recruiting
Research Team
M
Matthew MC McCall, PhD
S
Saskia C van der Boor, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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