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NCT01257763 · ClinicalTrials.gov registry record · Phase 1
Tolerability Study of the Application of a 3M Microstructure Transdermal System
A Phase 1 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01257763 is a Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 54 participants.
The verdict
NCT01257763, a Phase 1 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of an experimental device that introduces microscopic channels into the skin. Creating microscopic channels in the skin allows for better absorption of various medications applied to the skin, and this study will determine if the study device offers a tolerable method by which to introduce these holes. The study population will include 54 individuals, ages 18-74 years old, with a roughly equal distribution of skin colors. Each subject will have a total of three visits 24 hours apart from one another. The study device will be applied at the Baseline and Day 1 visits. At various timepoints before and after device application, skin assessments for irritation will be completed using a 7-point Skin Reaction Scale and photographs will be taken. Subjects will report pain associated with device application using a standardized pain scale. At the baseline visit, a member of the research staff will administer applications of the study device on the side of the subject's forehead, temple and the area below and to the side of the nose on randomly selected sides of the face. The side of the face at each location not receiving application of the study device will receive applications of a "dummy" device. Subjects will not be informed of which device is the study device and which is the "dummy" device. At the Day 1 visit, a member of the research staff will administer study device applications to the center of the subject's forehead. The subject will also self-apply the study device to the chin, under the instruction of the research staff member. At the Day 2 visit, final skin assessments will be made and the subject will be evaluated and treated for any persistent skin irritation. Differences in skin irritation between sites of study device application and "dummy" device application will be determined, as well as several other endpoints.
Interventions
- DEVICE Sham device
- DEVICE Transdermal Microchannel Skin System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2010-05 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01257763
The ClinicalTrials.gov registry entry for NCT01257763 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham device is the first listed.
NCT01257763 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01257763 about?
NCT01257763 is a clinical study titled "Tolerability Study of the Application of a 3M Microstructure Transdermal System". The purpose of this study is to evaluate the safety and tolerability of an experimental device that introduces microscopic channels into the skin. Creating microscopic channels in the skin allows for better absorption of various medications applied to the skin, and this study will determine if the s...
What is the current status of trial NCT01257763?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2010-05. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01257763?
The interventions under investigation include: Sham device (DEVICE), Transdermal Microchannel Skin System (DEVICE).
Who is sponsoring clinical trial NCT01257763?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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