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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: Completed NA study, sponsored by James J. Peters Veterans Affairs Medical Center.

NCT04027959 is a NA study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

micrograms

Interventions

  • DIETARY_SUPPLEMENT Vitamin B12

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2017-10-05
Est. Completion 2018-11-01
Phase NA

What the finished NCT04027959 record still lists

NCT04027959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Vitamin B12 is the first listed.

NCT04027959 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04027959's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04027959, the US trial registry maintained by the National Library of Medicine. NCT04027959 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.