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NCT04027959 · ClinicalTrials.gov registry record · NA
Transdermal Iontophoresis of Vitamin B12 Under Three Different Skin Preparations
A NA study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT04027959 is a NA study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT04027959, a NA study, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
STUDY DESIGN: Phase I Clinical Trial The researchers set out to assess the effectiveness of transdermal iontophoretic administration of Vitamin B12 (V.B12) under three different skin preparatory conditions. SETTING: James J. Peters Veterans Affairs Medical Center (Bronx, NY) BACKGROUND: Poor skin permeability precludes the use of transdermal route from being used in common clinical practice for rapid and precise administration of medications through intact skin that are expected to have a systemic effect. The researchers determined the relative effectiveness of an unconventional transdermal iontophoresis technique for the administration of Vitamin B12 (V.B12) under three different skin preparatory conditions. METHODS: During this study, Vitamin B12 (V.B12) was administered through the skin of volunteer human research subjects. Iontophoresis was used as transdermal medication delivery modality after pre-treatment of the skin in 3 different ways. The sequence of skin preparations was arranged in a random order for each subject. Method 1 was called "No Prep", serving as the control approach; method 2 was called "Oleic Acid" application to the skin for 40 minutes; and method 3 was hair "Epilation" (e.g. hair removal by plucking). Fifteen milligrams of aqueous solution of V.B12 was administered through intact, previously unused skin of an anterior thigh during all 3 tests. Chemoluminescence, on an automated laboratory reader Advia Centaur-XP, was used to determine the serum concentration of V.B12 prior to and after transdermal iontophoretic delivery. All 3 experiments were performed on the same day within an hour of each other. The subject's blood was drawn prior and 10 minutes after the 20-minute long sessions of transdermal V.B12 iontophoresis. We were able to calculate the increase in serum V.B12 concentration and based on estimated blood volume, the total quantity and percent dose delivered systemically.
Interventions
- DIETARY_SUPPLEMENT Vitamin B12
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-10-05 |
| Est. Completion | 2018-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04027959
The ClinicalTrials.gov registry entry for NCT04027959 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vitamin B12 is the first listed.
NCT04027959 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04027959 about?
NCT04027959 is a clinical study titled "Transdermal Iontophoresis of Vitamin B12 Under Three Different Skin Preparations". STUDY DESIGN: Phase I Clinical Trial The researchers set out to assess the effectiveness of transdermal iontophoretic administration of Vitamin B12 (V.B12) under three different skin preparatory conditions. SETTING: James J. Peters Veterans Affairs Medical Center (Bronx, NY) BACKGROUND: Poor skin p...
What is the current status of trial NCT04027959?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2017-10-05. Estimated completion is 2018-11-01.
What interventions are being tested in trial NCT04027959?
The interventions under investigation include: Vitamin B12 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04027959?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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