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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02254564
Other study ID # Scabies 1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date October 31, 2017

Study information

Verified date June 2018
Source Seton Healthcare Family
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective of this study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through PCR.


Description:

The main objective of this proposed study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through polymerase chain reaction or PCR. The goal of the project is to design an assay that can distinguish samples from skin scrapings containing scabies mites, eggs, or fecal material confirmed by clinic based microscopic evaluation (gold standard) from negative controls (i.e. scrapings for tinea and/or demodex folliculitis) that do not contain Sarcoptes scabiei. We hypothesize that specifically amplifying the unique regions of the Scabies genome using PCR can serve as a means to diagnosis infestations in humans. To address this question, we will optimize PCR amplification of known scabies samples then apply our procedure to DNA extracted from patient samples.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date October 31, 2017
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 1. Male/Female of all ages whose standard clinical treatment produces one or more of the following:

- Slides from skin scrapings containing scabies mites, eggs, and/or fecal material

- Slides from skin scrapings of suspected tinea

- Slides from skin scrapings of demodex mites

Exclusion Criteria:

- 1. Patients who are clinically concerning for having both scabies and tinea/demodex folliculitis to avoid contamination of positive and negative controls in the same sample. Subjects or guardians who cannot understand and read English and so are unable to consent to participation.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children Austin Texas
United States Seton Family of Hospitals- Trinity and Hays Clinic Austin Texas
United States University Medical Center Brackenridge and Paul Bass Clinic Austin Texas
United States University of Texas Physicians at Trinity Austin Texas
United States Seton Family of Hospitals- Seton Luling Family Medicine Clinic and Lockhart Specialty Clinic Lockhart Texas

Sponsors (1)

Lead Sponsor Collaborator
Seton Healthcare Family

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of DNA sequences within scabies that can be used to identify the parasite through PCR 1 year
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