Transdermal Iontophoresis of Vitamin B12 Under Three Different Skin Preparations

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12) for anemia.

It had three arms (groups): Epilation (experimental), Oleic Acid (experimental) and No Prep (experimental).

Hair epilated prior to application of Vitamin B12 solution to skin.

Oil is allowed to soak the skin prior to application of Vitamin B12 solution to skin.

Skin is cleansed with an alcohol wipe prior to application of Vitamin B12 solution to skin.

The registry classes the interventions as dietary supplement.

More on the Plan

In order to quantify the changes in skin permeability to drugs delivered by ION under three different preparatory conditions, the researchers used V.B12 as a model substance.

Its choice was dictated by its inherent safety, positive charge and quantification of serum concentration readily available through their clinical laboratory.

The researchers compared the effects of unprepared skin (No Prep), oil-soaked skin \[ref. 9-12\] (Oleic Acid) and skin from which hair have been plucked out of (Epilation), on the serum concentrations of V.B12 before and after administration via ION.

The skin was prepared using 1 of the 3 techniques, performed in a random order.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female,. Between the ages of 18-80 years old.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: previous adverse reaction or hypersensitivity to electrical stimulation,; inability to provide informed consent,; history of ingrown hair folliculitis after shaving or epilation,.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the anemia participants took both Cyanocobalamin (Vitamin B12) and the comparison in turn, acting as their own control.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

It started in 2017-10-05 with completion listed for 2018-10-04.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Amount of Vitamin B12 delivered into the systemic circulation (time frame: 20 minutes).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 10 people with anemia.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, Anemia research.