Transdermal Iontophoresis of Vitamin B12 Under Three Different Skin Preparations

NCT04027959 | Completed DMC

• 1 other identifier: KOR-17-34
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Macrocytic Anemia With Vitamin B12 Deficiency

Keywords

Transdermal Penetration Enhancers, Iontophoresis, Neostigmine, Glycopyrrolate, Vitamin B12, Methylcobalamin, Cyanocobalamin

Outcome Measures

Primary Outcomes (1)

• Amount of Vitamin B12 delivered into the systemic circulation

  micrograms

  20 minutes

Study Arms (3)

Epilation

EXPERIMENTAL

Hair epilated prior to application of Vitamin B12 solution to skin

Dietary Supplement: Vitamin B12

Oleic Acid

EXPERIMENTAL

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

Dietary Supplement: Vitamin B12

No Prep

EXPERIMENTAL

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

Dietary Supplement: Vitamin B12

Interventions

Vitamin B12 DIETARY_SUPPLEMENT

Diffusion of Vitamin B12 through the skin over 20 minutes under the effect of low amount of direct electric current

Also known as: Iontophoresis

Epilation; No Prep; Oleic Acid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Interventions

Vitamin B 12; Iontophoresis

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques

Study Officials

• Mark Korsten, MD

  Employee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Senior Consultant

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 22, 2019
• Study Start: October 5, 2017
• Primary Completion: October 4, 2018
• Study Completion: November 1, 2018
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)