Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546579
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Sensitivity of Self-collected Skin Sampling for Scabies a Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sensitivity of Self-collected Skin Sampling for Scabies a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCRAPE
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None