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PKU Skin Stripping

NCT04368624 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2021-07-28

No results posted yet for this study

Summary

PURPOSE OF STUDY: To determine if a non-invasive skin stripping technique can be used to detect individuals with phenylalanine abnormalities, and to monitor dietary and/or drug effects over time.

Conditions

  • Phenylketonurias

Interventions

OTHER

Skin Tape

Skin sample collection: samples of human stratum corneum will be obtained with squame adhesive tape disks typically at the time of their clinic appointment. The tape will be placed on the inside of the forearm and the procedure will be repeated up to five times per patient to have sufficient corneocytes for analysis. This type of sampling is non-invasive.

DIAGNOSTIC_TEST

Blood Draw

Blood specimens: blood will be obtained for serum amino acids/phenylalanine levels. This sample is obtained for disease monitoring as part of routine standard of care. Results from up to three clinic visits will be correlated with the tape sample obtained on the same day.

Sponsors & Collaborators

Principal Investigators

  • Carlos E Prada, MD · Children's Hospital Medical Center, Cincinnati

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-12
Primary Completion
2020-12-31
Completion
2021-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04368624 on ClinicalTrials.gov