PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei
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ClinicalTrials.gov Identifier: NCT02254564 |
Recruitment Status :
Completed
First Posted : October 2, 2014
Last Update Posted : July 3, 2018
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Condition or disease |
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Scabies |
Study Type : | Observational |
Actual Enrollment : | 17 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei |
Actual Study Start Date : | October 2014 |
Actual Primary Completion Date : | August 2017 |
Actual Study Completion Date : | October 31, 2017 |
Group/Cohort |
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Positive Scrapings
Skin scrapings that are positive for scabies
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Negative Controls
collect negative controls from patients in whom tinea (superficial fungal infection) was clinically suspected. Samples from patients with demodex folliculitis (a mite that is commonly found in oil glands on the face) are also intended to be used as negative controls as well.
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- Identification of DNA sequences within scabies that can be used to identify the parasite through PCR [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254564
United States, Texas | |
Seton Family of Hospitals- Trinity and Hays Clinic | |
Austin, Texas, United States, 78701 | |
University Medical Center Brackenridge and Paul Bass Clinic | |
Austin, Texas, United States, 78701 | |
University of Texas Physicians at Trinity | |
Austin, Texas, United States, 78701 | |
Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children | |
Austin, Texas, United States, 78723 | |
Seton Family of Hospitals- Seton Luling Family Medicine Clinic and Lockhart Specialty Clinic | |
Lockhart, Texas, United States, 78644 |
Principal Investigator: | Dayna Diven, MD | Seton Healthcare Family |
Responsible Party: | Dayna Diven, Physician, Seton Healthcare Family |
ClinicalTrials.gov Identifier: | NCT02254564 |
Other Study ID Numbers: |
Scabies 1 |
First Posted: | October 2, 2014 Key Record Dates |
Last Update Posted: | July 3, 2018 |
Last Verified: | June 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Scabies Mite Infestations Ectoparasitic Infestations Skin Diseases, Parasitic |
Parasitic Diseases Skin Diseases, Infectious Skin Diseases |