Transdermal Iontophoresis of Vitamin B12 Under Three Different Skin Preparations

Completed · Not applicable

Conditions studied: Macrocytic Anemia With Vitamin B12 Deficiency

In brief

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.

Key facts

Study ID

NCT04027959

Run by

James J. Peters Veterans Affairs Medical Center

People needed

10

Starts

2017-10-05

Expected to finish

2018-11-01

Last updated by the study team

2020-12-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able-bodied,
• Male or female,
• Between the ages of 18-80 years old.

You may not qualify if…

• Previous adverse reaction or hypersensitivity to electrical stimulation,
• Pregnancy (women who are sexually active and of childbearing potential must utilize a method of contraception and agree to maintain a contraceptive method until completion of the study),
• Inability to provide informed consent,
• History of ingrown hair folliculitis after shaving or epilation,
• Allergy to Sodium Lauryl Sulfate, Oleic acid, Silver Chloride, Agarose Gel, Methylcobalamin, Citric Acid, Isopropyl alcohol, Benzocaine, Polyethylene film, Polyethylene Glycol solvent,
• Concurrent illness with fever,
• Concurrent participation in a research study,
• VA employee.

Where it is running

• James J Peters VA Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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