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CompletedNCT02254564Updated Jul 3, 2018

PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei

An observational study in Scabies, sponsored by Seton Healthcare Family. Completed at 5 sites in United States. Per ClinicalTrials.gov, last updated 2018-07-03.

Sponsored by Seton Healthcare Family · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
17
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Scabies with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Scabies · United States.

Started
2014
with 1 other
Observational
Only one
of the 10
Registered
2nd of 10
by date
Lead sponsor
1 of 10
Seton Healthcare Family

Among the 10 studies in Scabies with a site in United States, this one is one of 2 that started in 2014, is the only observational one, and was the 2nd registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

Phase 36 · 0 open
Phase 22 · 0 open
Observationalthis study1 · 0 open
Phase 41 · 1 open

By the year they started

First in 2014; this study’s year is marked. 2 started in 2014.

What they test

Size and results

Median enrollment 200 across the 9 interventional studies, 17 across the 1 observational. Of the 9 that completed or were terminated, 6 (67%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies in Scabies with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed 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.

03

Conditions studied

  • Scabies

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04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients will be recruited upon identifying of scabies by microscopy or when a scraping is performed for suspected tinea or demodex folliculitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Positive Scrapings

    Skin scrapings that are positive for scabies

  • 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.

06

What researchers measure

Primary outcomes

  1. Identification of DNA sequences within scabies that can be used to identify the parasite through PCR

    Time frame: 1 year

07

Study locations

5 sites
  • Seton Family of Hospitals- Trinity and Hays Clinic
    Austin, Texas 78701, United States
  • University Medical Center Brackenridge and Paul Bass Clinic
    Austin, Texas 78701, United States
  • University of Texas Physicians at Trinity
    Austin, Texas 78701, United States
  • Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children
    Austin, Texas 78723, United States
  • Seton Family of Hospitals- Seton Luling Family Medicine Clinic and Lockhart Specialty Clinic
    Lockhart, Texas 78644, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2014 to primary completion in Aug 2017, 34 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2014
First posted
Oct 2, 2014
StartActual
Oct 2014
Primary completionActual
Aug 2017
CompletionActual
Oct 31, 2017
Last update
Jul 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02254564
Lead sponsor
Seton Healthcare Family
Responsible party
Dayna Diven (Physician, Seton Healthcare Family) — Principal investigator
First posted
Oct 2, 2014
Start date
Oct 2014
Primary completion
Aug 2017
Completion
Oct 31, 2017
Last update
Jul 3, 2018

Study contacts

Dayna Diven, MD
principal investigator · Seton Healthcare Family

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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